S0424 - Carcinogens in Lung Tissue From Smokers (Closed to Entry as of 7/15/07) and Non-Smokers With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

October 23, 2015 updated by: Southwest Oncology Group

Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men

RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future.

PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

Study Overview

Detailed Description

OBJECTIVES:

  • Assess lung tissue from patients with stage I, stage II, stage IIIA, or stage IIIB non-small cell lung cancer for specific tobacco smoke carcinogens (including polycyclic aromatic hydrocarbons [PAH] and DNA adducts, alterations in specific genes, including p53 and K-ras, and expression of HER2 and estrogen receptors α and β).
  • Determine whether tobacco smoke carcinogens differ by gender and smoking status, adjusting for potential exposures and influential factors, including family smoking status, medication use, and hormonal and reproductive factors.
  • Measure the levels of PAH-DNA adducts in lymphocytes and lung tissue and examine correlations between the two tissue sources.
  • Determine whether DNA damage levels in tissue as well as in lymphocytes are higher in females than in males for the same level of smoking.
  • Determine polymorphisms in several genes involved in the metabolism of the specific carcinogens investigated and in steroidogenesis and metabolism.
  • Summarize patient self-report questionnaire data on active and passive smoking, other carcinogenic exposures, smoking preference, economic and educational status, family smoking status, reproductive factors, weight loss, and medication use by categories of male versus female and never-smoker versus ever-smoker.

OUTLINE: This is a case-series, multicenter study. Patients are stratified according to gender and smoking status (never smoker [< 100 cigarettes smoked during lifetime] vs ever smoker [≥ 100 cigarettes smoked during lifetime] [closed to accrual as of 7/15/07]).

Patients complete the Lung Cancer Epidemiology Questionnaire for detailed assessment of the following:

  • Exposure to active and passive smoke
  • Occupational exposures
  • Reproductive and hormonal risk factors
  • Weight loss
  • Economic and educational status
  • Family smoking status
  • Medication use
  • Other variables relevant for the analysis (e.g., HER2, estrogen receptor status) Peripheral blood samples are collected for research studies. Previously collected tissue samples are also studied in the laboratory. Samples are examined for DNA adduct levels. Estrogen receptor α and β are assessed by immunohistochemistry (IHC). HER2 expression and amplification are measured by chromogenic in situ hybridization. IHC and DNA-polymerase chain reaction (PCR)-single-stranded conformational polymorphism assay are used to analyze p53 mutations. RAS mutations are analyzed with restriction fragment length polymorphism-PCR assay. Polycyclic aromatic hydrocarbons and 4-aminobiphenyl-DNA damage are assessed by IHC and immunofluorescence. Matrix-assisted laser desorption/ionization time of flight mass spectrometry is used to genotype polymorphisms, including CYP1A1, CYP1B1, GSTM1, GSTP1, MPO, NAT-1, NAT-2, CYP19, CYP17, SULT1A1.

Patients are followed annually for up to 5 years.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study (female and male smoker strata closed to accrual as of 7/15/07).

Study Type

Observational

Enrollment (Actual)

981

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Cancer Center
    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Ft. Smith, Arkansas, United States, 72903
        • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente - Deer Valley
      • Burbank, California, United States, 91505
        • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
      • Concord, California, United States, 94524-4110
        • Cancer Care Center at John Muir Health - Concord Campus
      • Fairfield, California, United States, 94533
        • North Bay Cancer Center
      • Fremont, California, United States, 94538
        • Kaiser Permanente - Fremont
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital Comprehensive Cancer Center
      • Hayward, California, United States, 94545
        • Kaiser Permanente Medical Center - Hayward
      • Marysville, California, United States, 95901
        • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
      • Oakland, California, United States, 94611
        • Kaiser Permanente Medical Center - Oakland
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Pleasanton, California, United States, 94588
        • Valley Care Medical Center
      • Pomona, California, United States, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente Medical Center - Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente Medical Center - Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente Medical Center - Roseville
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medical Center - San Francisco Geary Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente Medical Center - Santa Teresa
      • San Rafael, California, United States, 94903
        • Kaiser Foundation Hospital - San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente Medical Center - Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente Medical Center - South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente Medical Facility - Stockton
      • Truckee, California, United States, 96161
        • Tahoe Forest Cancer Center
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center - Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Medical Center - Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital Cancer Center - Colorado Springs
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente - Denver
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente - Lafayette
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Jupiter, Florida, United States, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Stuart, Florida, United States, 34994
        • Robert and Carol Weissman Cancer Center at Martin Memorial
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, United States, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30342
        • CCOP - Atlanta Regional
      • Austell, Georgia, United States, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, United States, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274-2600
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Cancer Center - Medical Oncology
      • Savannah, Georgia, United States, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah, Georgia, United States, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente - Moanalua Medical Center and Clinic
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Cancer Care Center
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60657
        • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • La Grange, Illinois, United States, 60525
        • La Grange Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital Cancer Center
      • Springfield, Illinois, United States, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Bloomington, Indiana, United States, 47403
        • Bloomington Hospital Regional Cancer Institute
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • Richmond, Indiana, United States, 47374
        • Reid Hospital & Health Care Services
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, United States, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Anthony, Kansas, United States, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Hays, Kansas, United States, 67601
        • Hays Medical Center
      • Hutchinson, Kansas, United States, 65702
        • Hutchinson Hospital Corporation
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's Hospital - South
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pittsburg, Kansas, United States, 66762
        • Mount Carmel Regional Cancer Center
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas, PA - Salina
      • Shawnee Mission, Kansas, United States, 66204
        • Shawnee Mission Medical Center
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Cancer Center
      • Topeka, Kansas, United States, 66606
        • St. Francis Comprehensive Cancer Center
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Ashland, Kentucky, United States, 41101-0151
        • Cancer Resource Center at King's Daughters Medical Center
      • Louisville, Kentucky, United States, 40202-1886
        • Jewish Hospital
    • Louisiana
      • Monroe, Louisiana, United States, 71210
        • Louisiana State University Health Sciences Center - Monroe
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Massachusetts
      • Attleboro, Massachusetts, United States, 02703
        • Sturdy Memorial Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University Cancer Research Center
      • Brighton, Massachusetts, United States, 02135-2997
        • Caritas St. Elizabeth's Medical Center
      • Methuen, Massachusetts, United States, 01844
        • Caritas Holy Family Hospital
      • Norwood, Massachusetts, United States, 02062
        • Caritas Norwood Hospital
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Bay City, Michigan, United States, 48708
        • Bay Regional Medical Center
      • Dearborn, Michigan, United States, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, United States, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, United States, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Lambertville, Michigan, United States, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Lansing, Michigan, United States, 48912-1811
        • Sparrow Regional Cancer Center
      • Lansing, Michigan, United States, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Livonia, Michigan, United States, 48154
        • St. Mary Mercy Hospital
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital - Monroe
      • Mount Clemens, Michigan, United States, 48043
        • Clemens Regional Medical Center
      • Pontiac, Michigan, United States, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, United States, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
      • Warren, Michigan, United States, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, United States, 55805
        • Miller - Dwan Medical Center
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital Cancer Care Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, United States, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center - Hospital Hill
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology, Incorporated
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care and Research
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
      • Saint Louis, Missouri, United States, 63109
        • Midwest Hematology Oncology Group, Incorporated
      • Saint Louis, Missouri, United States, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Saint Louis, Missouri, United States, 63141
        • Comprehensive Cancer Care, PC
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, United States, 59405
      • Great Falls, Montana, United States, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Estabrook Cancer Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, United States, 03246
        • Lakes Region General Hospital
      • Manchester, New Hampshire, United States, 03103
        • Elliot Regional Cancer Center at Elliot Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • New York, New York, United States, 10025
        • St. Luke's - Roosevelt Hospital Center - St.Luke's Division
      • New York, New York, United States, 10003-3803
        • Beth Israel Medical Center - Petrie Division
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, United States, 14620
        • Highland Hospital of Rochester
      • Rochester, New York, United States, 14621
        • Lipson Cancer and Blood Center at Rochester General Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals - Memorial Campus
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Gastonia, North Carolina, United States, 28053
        • CaroMont Cancer Center at Gaston Memorial Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • High Point, North Carolina, United States, 27261
        • High Point Regional Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Minot, North Dakota, United States, 58701
        • Trinity Cancercare Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, United States, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Barberton, Ohio, United States, 44203
        • Barberton Citizens Hospital
      • Bellefontaine, Ohio, United States, 43311
        • Mary Rutan Hospital
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Canton, Ohio, United States, 44708
        • Mercy Cancer Center at Mercy Medical Center
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital Cancer Treatment Center
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care - Clyde
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, United States, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, United States, 45420
        • CCOP - Dayton
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, United States, 44035
        • Community Cancer Center
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, United States, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Marietta, Ohio, United States, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, United States, 43537-1839
        • Northwest Ohio Oncology Center
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Salem, Ohio, United States, 44460
        • Cancer Care Center, Incorporated
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Springfield, Ohio, United States, 45505
        • Community Hospital of Springfield and Clark County
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, United States, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, United States, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westerville, Ohio, United States, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Wooster, Ohio, United States, 44691
        • Cancer Treatment Center
      • Wright-Patterson Afb, Ohio, United States, 45433-5529
        • United States Air Force Medical Center - Wright-Patterson
      • Xenia, Ohio, United States, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Willamette Falls Hospital
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Easley, South Carolina, United States, 29640
        • Cancer Centers of the Carolinas - Easley
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital Cancer Center
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Faris Road
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas - Grove Commons
      • Greenville, South Carolina, United States, 29601
        • Bon Secours St. Francis Health System
      • Greenwood, South Carolina, United States, 29646
        • Self Regional Cancer Center at Self Regional Medical Center
      • Greer, South Carolina, United States, 29650
        • Cancer Centers of the Carolinas - Greer Medical Oncology
      • Greer, South Carolina, United States, 29650
        • Cancer Centers of the Carolinas - Greer Radiation Oncology
      • Seneca, South Carolina, United States, 29672
        • Cancer Centers of the Carolinas - Seneca
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Cancer Centers of the Carolinas - Spartanburg
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • H. Clay Evans Johnson Cancer Center at Memorial Hospital
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Knoxville, Tennessee, United States, 37920-6999
        • U.T. Medical Center Cancer Institute
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute at University of Utah
      • Salt Lake City, Utah, United States, 84103
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Mountainview Medical
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Martha Jefferson Hospital Cancer Care Center
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology, Incorporated
    • Washington
      • Bellingham, Washington, United States, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, United States, 98310
        • Olympic Hematology and Oncology
      • Centralia, Washington, United States, 98531-9027
        • Providence Centralia Hospital
      • Federal Way, Washington, United States, 98003
        • St. Francis Hospital
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology
      • Mt. Vernon, Washington, United States, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Olympia, Washington, United States, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Poulsbo, Washington, United States, 98370
        • Harrison Poulsbo Hematology and Onocology
      • Puyallup, Washington, United States, 98372
        • Good Samaritan Cancer Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, United States, 98112
        • Group Health Central Hospital
      • Seattle, Washington, United States, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, United States, 98122
        • Polyclinic First Hill
      • Seattle, Washington, United States, 98195
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology, PS
      • Tacoma, Washington, United States, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, United States, 98405
        • Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • CCOP - Northwest
      • Tacoma, Washington, United States, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, United States, 98499
        • St. Clare Hospital
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center - Tacoma
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists at Vancouver Cancer Center
      • Vancouver, Washington, United States, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, United States, 98801-2028
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic - Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Center for Cancer Treatment & Prevention at Sacred Heart Hospital
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Care at Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Manitowoc, Wisconsin, United States, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic - Lakeland Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Racine, Wisconsin, United States, 53405
        • All Saints Cancer Center at Wheaton Franciscan Healthcare
      • Rhinelander, Wisconsin, United States, 54501
        • Ministry Medical Group at Saint Mary's Hospital
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic - Indianhead Center
      • Stevens Point, Wisconsin, United States, 54481
        • Marshfield Clinic at Saint Michael's Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital Cancer Center
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic - Wausau Center
      • West Allis, Wisconsin, United States, 53227
        • West Allis Memorial Hospital
      • Weston, Wisconsin, United States, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer center

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Stage I, II, IIIA, or IIIB (T4 or N3) disease
    • No malignant pleural effusion; if pleural fluid is present, 1 of the following criteria must be met:

      • Benign pleural fluid
      • Pleural fluid is due to prior thoracotomy
      • Pleural fluid is deemed too small to safely tap
    • No diagnosis by cytology alone
  • Newly diagnosed disease
  • Must have tumor blocks/slides available and must be willing to provide tissue samples
  • Prior smoking history meeting 1 of the following criteria:

    • Never smoker, defined as < 100 cigarettes in lifetime
    • Former smoker, defined as no smoking for ≥ 1 year
    • Current smoker, defined as all others (closed to accrual as of 7/15/07)
  • No pericardial effusions

PATIENT CHARACTERISTICS:

  • No other prior malignancy except for 1 of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Other cancer for which the patient has been disease free for five years

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • Concurrent participation in therapeutic trials allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male, Never-smokers
Male subjects who smoked less than 100 cigarettes during their lifetime.
Male, Ever-smokers
Male subjects who have smoked at least 100 cigarettes during their lifetime.
Female, Ever-smokers
Female subjects who have smoked less than 100 cigarettes during their lifetime.
Female, Never-smokers
Female subjects who have smoked at least 100 cigarettes during their lifetime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DNA adduct levels
Time Frame: End of study
End of study
Tumor tissue alterations
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Christine B. Ambrosone, PhD, Roswell Park Cancer Institute
  • Study Chair: Regina M. Santella, PhD, Herbert Irving Comprehensive Cancer Center
  • Study Chair: Paul H. Gumerlock, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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