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Undersøgelse af biomarkører forbundet med træthed hos patienter med tidligt stadie af brystkræft behandlet med metformin eller placebo på NCIC-CTG-MA.32

8. september 2015 opdateret af: NSABP Foundation Inc

Bioadfærdsmæssige mekanismer for træthed hos patienter behandlet på NCIC CTG MA.32: Et fase III randomiseret forsøg med metformin versus placebo om recidiv og overlevelse i tidligt stadie af brystkræft

RATIONALE: At studere blodprøver i laboratoriet fra patienter med brystkræft kan hjælpe læger med at lære mere om ændringer, der opstår i DNA, og identificere biomarkører relateret til træthed.

FORMÅL: Dette forskningsstudie studerer biomarkører forbundet med træthed hos patienter med tidligt stadie af brystkræft behandlet med metformin eller placebo på NCIC-CTG-MA.32.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • At forberede, adskille i komponenter og opbevare blodprøverne i NSABP Serum Bank ved Baylor College of Medicine Breast Center til fremtidig DNA-, RNA- og plasmaanalyse og analysere specifikke proinflammatoriske cytokiner, genetiske polymorfismer og RNA-ekspressionsarrays i samarbejde laboratorier ved University of California, Los Angeles (UCLA).
  • At undersøge sammenhængen mellem markører for inflammation og symptomer på træthed blandt patienter med og uden eksponering for metforminhydrochlorid.
  • At undersøge forholdet mellem enkeltnukleotidpolymorfi (SNP'er) i promotorregionerne af IL-1 og IL-6 og symptomer på træthed med og uden eksponering for metforminhydrochlorid.
  • At undersøge RNA-ekspressionsprofiler i forhold til træthed og sammenligne ekspressionsmønsteret hos patienter med og uden eksponering for metforminhydrochlorid.
  • At bestemme de biologiske og adfærdsmæssige prædiktorer for træthed hos brystkræftpatienter i de fem år efter randomisering.
  • For at bestemme om metformin er forbundet med reduktioner i inflammatoriske markører og tilsvarende fald i træthed. (Undersøgende)

OVERSIGT: Dette er en multicenterundersøgelse.

Patienternes serum og plasma, opsamlet ved baseline og 6, 12 og 24 måneder efter NCIC CTG MA.32 randomisering, analyseres for inflammatoriske markører, DNA-polymorfismer og RNA-ekspressionsarrays ved ELISA, TaqMan PCR og RT-PCR.

Patienter udfylder træthedssymptomoversigten (symptomer forbundet med træthed, søvnforstyrrelser, depression og endokrin behandling) ved baseline og periodisk under undersøgelsen.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

394

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • Saint Catharines, Ontario, Canada, L2R 2Z7
        • St. Catharines General Hospital at Niagara Health System
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Forenede Stater
    • California
      • Anaheim, California, Forenede Stater, 92807
        • Kaiser Permanente Medical Center - Anaheim/Orange County
      • Antioch, California, Forenede Stater, 94531
        • Kaiser Permanente - Deer Valley
      • Baldwin Park, California, Forenede Stater, 91706
        • Kaiser Permanente Medical Center - Baldwin Park
      • Bellflower, California, Forenede Stater, 90706
        • Kaiser Permanente Medical Center - Bellflower
      • Fontana, California, Forenede Stater, 92335
        • Kaiser Permanente Medical Center - Fontana
      • Fremont, California, Forenede Stater, 94538
        • Kaiser Permanente - Fremont
      • Harbor City, California, Forenede Stater, 90710
        • Kaiser Permanente Medical Center - Harbor City
      • Hayward, California, Forenede Stater, 94545
        • Kaiser Permanente Medical Center - Hayward
      • Irvine, California, Forenede Stater, 92618
        • Kaiser Permanente - Irvine
      • Los Angeles, California, Forenede Stater, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Los Angeles, California, Forenede Stater, 90034
        • Kaiser Foundation Hospital - West Los Angeles
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente Medical Center - Oakland
      • Ontario, California, Forenede Stater, 91761
        • Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
      • Panorama City, California, Forenede Stater, 91402
        • Kaiser Permanente Medical Group
      • Redwood City, California, Forenede Stater, 94063
        • Kaiser Permanente Medical Center - Redwood City
      • Richmond, California, Forenede Stater, 94801
        • Kaiser Permanente Medical Center - Richmond
      • Riverside, California, Forenede Stater, 92505
        • Kaiser Permanente Medical Center - Riverside
      • Roseville, California, Forenede Stater, 95661
        • Kaiser Permanente Medical Center - Roseville
      • Sacramento, California, Forenede Stater, 95823
        • South Sacramento Kaiser-Permanente Medical Center
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
      • San Diego, California, Forenede Stater, 92108
        • Kaiser Permanente Medical Office -Vandever Medical Office
      • San Francisco, California, Forenede Stater, 94115
        • Kaiser Permanente Medical Center - San Francisco Geary Campus
      • San Jose, California, Forenede Stater, 95119
        • Kaiser Permanente Medical Center - Santa Teresa
      • San Marcos, California, Forenede Stater, 92078
        • Kaiser Permanente Health Care
      • San Rafael, California, Forenede Stater, 94903
        • Kaiser Foundation Hospital - San Rafael
      • Santa Clara, California, Forenede Stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Santa Rosa, California, Forenede Stater, 95403
        • Kaiser Permanente Medical Center - Santa Rosa
      • South San Francisco, California, Forenede Stater, 94080
        • Kaiser Permanente Medical Center - South San Francisco
      • Stockton, California, Forenede Stater, 95210
        • Kaiser Permanente Medical Facility - Stockton
      • Vacaville, California, Forenede Stater, 95688
        • Kaiser Permanente Medical Center - Vacaville
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente Medical Center - Vallejo
      • Walnut Creek, California, Forenede Stater, 94596
        • Kaiser Permanente Medical Center - Walnut Creek
      • Woodland Hills, California, Forenede Stater, 91367
        • Kaiser Permanente Medical Cener - Woodland Hills
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Front Range Cancer Specialists
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Georgia
      • Albany, Georgia, Forenede Stater, 31701
        • Phoebe Cancer Center at Phoebe Putney Memorial Hospital
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96819
        • Kaiser Permanente - Moanalua Medical Center and Clinic
    • Idaho
      • Lewiston, Idaho, Forenede Stater, 83501
        • St. Joseph Regional Medical Center
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Bloomington%, Illinois, Forenede Stater, 61701
        • Illinois CancerCare - Bloomington
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare - Carthage
      • Chicago, Illinois, Forenede Stater, 60631
        • Resurrection Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Community Hospital
      • Evanston, Illinois, Forenede Stater, 60201-1781
        • Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare - Galesburg
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Clinic, PC
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Moline, Illinois, Forenede Stater, 61265
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • OSF Holy Family Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forenede Stater, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Forenede Stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, Forenede Stater, 61603
        • Illinois CancerCare - Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forenede Stater, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare - Princeton
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Illinois CancerCare - Spring Valley
      • Springfield, Illinois, Forenede Stater, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
      • Warrenville, Illinois, Forenede Stater, 60555
        • Central Dupage Cancer Center
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forenede Stater, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, Forenede Stater, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Forenede Stater, 46360
        • Saint Anthony Memorial Health Centers
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, Forenede Stater, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, Forenede Stater, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Bettendorf, Iowa, Forenede Stater, 52722
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Ottumwa, Iowa, Forenede Stater, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Forenede Stater, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forenede Stater, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas, PA - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503-9985
        • Central Baptist Hospital
    • Maine
      • York, Maine, Forenede Stater, 03909
        • York Hospital's Oncology Treatment Center
    • Maryland
      • Frederick, Maryland, Forenede Stater, 21701
        • Frederick Memorial Hospital Regional Cancer Therapy Center
    • Massachusetts
      • Gloucester, Massachusetts, Forenede Stater, 01930
        • Addison Gilbert Hospital
      • Lowell, Massachusetts, Forenede Stater, 01854
        • Lowell General Hospital
    • Michigan
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Forenede Stater, 49307
        • Mecosta County Medical Center
      • Escanaba, Michigan, Forenede Stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Dickinson County Healthcare System
      • Muskegon, Michigan, Forenede Stater, 49444
        • Mercy General Health Partners
      • Reed City, Michigan, Forenede Stater, 49677
        • Spectrum Health Reed City Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
    • Minnesota
      • Brainerd, Minnesota, Forenede Stater, 56401
        • St. Joseph's Medical Center
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Forenede Stater, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forenede Stater, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology - Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St. Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology - Woodbury
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Saint Luke's Hospital
      • Saint Louis, Missouri, Forenede Stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Midwest Hematology Oncology Group, Incorporated
      • Saint Louis, Missouri, Forenede Stater, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Forenede Stater, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68131-2197
        • Creighton University Medical Center
      • Omaha, Nebraska, Forenede Stater, 68114
        • Methodist Estabrook Cancer Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Lakeside Hospital
    • New Hampshire
      • Concord, New Hampshire, Forenede Stater, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, Forenede Stater, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, Forenede Stater, 03246
        • Lakes Region General Hospital
    • New Jersey
      • Marlton, New Jersey, Forenede Stater, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • East Syracuse, New York, Forenede Stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Lake Success, New York, Forenede Stater, 11042
        • Monter Cancer Center of the North Shore-LIJ Health System
      • Manhasset, New York, Forenede Stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forenede Stater, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, Forenede Stater, 11040
        • Long Island Jewish Medical Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-9446
        • Stony Brook University Cancer Center
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospitals - Memorial Campus
      • Gastonia, North Carolina, Forenede Stater, 28053
        • CaroMont Cancer Center at Gaston Memorial Hospital
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Pardee Memorial Hospital
      • High Point, North Carolina, Forenede Stater, 27261
        • High Point Regional Hospital
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Rex Cancer Center at Rex Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • Dakota Cancer Institute at Dakota Clinic - South University
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancercare Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Canton, Ohio, Forenede Stater, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
    • Oregon
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Milwaukie, Oregon, Forenede Stater, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forenede Stater, 97045
        • Willamette Falls Hospital
      • Portland, Oregon, Forenede Stater, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forenede Stater, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Kaiser Permanente Health Care - Portland
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, Forenede Stater, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Cancer Center
      • Phoenixville, Pennsylvania, Forenede Stater, 19460
        • Cancer Center at Phoenixville Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Cancer Centers
      • West Chester, Pennsylvania, Forenede Stater, 19380
        • Chester County Hospital
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - Main Line Health
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Cancer Center
      • Florence, South Carolina, Forenede Stater, 29501
        • McLeod Regional Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Texas
      • Laredo, Texas, Forenede Stater, 78045
        • Doctor's Hospital of Laredo
    • Vermont
      • Berlin, Vermont, Forenede Stater, 05602
        • Mountainview Medical
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Cancer Center at Overlake Hospital Medical Center
      • Centralia, Washington, Forenede Stater, 98531-9027
        • Providence Centralia Hospital
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Forenede Stater, 98003
        • St. Francis Hospital
      • Olympia, Washington, Forenede Stater, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Puyallup, Washington, Forenede Stater, 98372
        • Good Samaritan Cancer Center
      • Tacoma, Washington, Forenede Stater, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Allenmore Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • CCOP - Northwest
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, Forenede Stater, 98499
        • St. Clare Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • Southwest Washington Medical Center Cancer Center
    • Wisconsin
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Care at Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic - Marshfield Center
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic - Lakeland Center
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patienter med brystkræft, som er blevet diagnosticeret og har gennemgået definitiv kirurgisk behandling for invasiv brystkræft inden for de foregående 12 måneder, og som er berettiget til randomisering til NCIC MA.32.

Beskrivelse

Inklusionskriterier

  • Patienten skal have givet samtykke til at deltage og skal have underskrevet og dateret en passende IRB-godkendt samtykkeformular, der er i overensstemmelse med føderale og institutionelle retningslinjer for MA.32.F-undersøgelsen, før han tilmeldes.
  • Patienten skal være kvinde.
  • Patienten skal være bosat i USA eller Canada.
  • Patienten skal være engelsktalende.
  • Patienten skal være berettiget til randomisering i MA.32 behandlingsforsøget. (Deltagelse i MA.32 QOL-studiet er tilladt, men ikke påkrævet).
  • Patienten må ikke være begyndt at tage MA.32 studieterapi.
  • Patienten skal have afsluttet primær bryststrålebehandling mindst to uger før indskrivning i MA.32.F.

Eksklusionskriterier

  • MA.32 studieterapi er påbegyndt.
  • Modtager i øjeblikket strålebehandling eller yderligere strålebehandling er planlagt til påbegyndelse efter start af MA.32 studieterapi.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Gruppe 1: Metformin
850 mg oralt to gange dagligt i 5 år
Medicin: Metformin
Gruppe 2: Placebo
En caplet oralt to gange dagligt i 5 år
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Spørgeskemascore fra patientrapporterede resultatbatteri vedrørende træthed, stress, søvn, depression og generel livskvalitet
Tidsramme: Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
Spørgeskemascore fra patientrapporterede komorbide tilstande og adfærdsmæssige risici
Tidsramme: Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
Biologiske korrelater af træthed (medicinske og demografiske karakteristika ved pkt.)
Tidsramme: Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
Biologiske korrelater (medicinske) vil blive indsamlet på disse tidspunkter. Standard demografi vil kun blive indsamlet ved baseline.
Samlet ved baseline og 6, 12, 24 og 36 måneder fra randomisering
DNA polymorfismer
Tidsramme: Samlet ved baseline
Samlet ved baseline
Ændringer i RNA-genekspression
Tidsramme: Samlet ved baseline og 6, 12 og 24 måneder
Samlet ved baseline og 6, 12 og 24 måneder

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NSABP Foundation Inc

Samarbejdspartnere

National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Forventet)

1. september 2016

Studieafslutning (Forventet)

1. september 2016

Datoer for studieregistrering

Først indsendt

27. januar 2011

Først indsendt, der opfyldte QC-kriterier

27. januar 2011

Først opslået (Skøn)

31. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NSABP MA.32.F
  • NSABP-NCIC-CTG-MA.32.F

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Croatia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner