Genetic Study of Young Patients With Colorectal Cancer
A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age.
PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer.
- Evaluate the development of metachronous neoplasms in this patient population.
- Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population.
OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative).
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.
The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.
Patients may be referred for genetic counseling.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Alabama
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Mobile, Alabama, Förenta staterna, 36640-0460
- Mobile Infirmary Medical Center
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Mobile, Alabama, Förenta staterna, 36608
- Providence Cancer Center
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California
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Colton, California, Förenta staterna, 92324-1819
- Arrowhead Regional Medical Center
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Duarte, California, Förenta staterna, 91010-3000
- City of Hope Comprehensive Cancer Center
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San Francisco, California, Förenta staterna, 94115
- UCSF Comprehensive Cancer Center
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Florida
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Clearwater, Florida, Förenta staterna, 33756
- Morton Plant Hospital
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Fort Lauderdale, Florida, Förenta staterna, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Gainesville, Florida, Förenta staterna, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Tampa, Florida, Förenta staterna, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Gainesville, Georgia, Förenta staterna, 30501
- Surgical Oncology of Northeast Georgia
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Illinois
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Arlington Heights, Illinois, Förenta staterna, 60005
- Northwest Community Hospital
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Aurora, Illinois, Förenta staterna, 60504-4206
- Rush Copley Medical Center
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Förenta staterna, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Maywood, Illinois, Förenta staterna, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University Cancer Center
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Iowa
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Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Iowa City, Iowa, Förenta staterna, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503-9985
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Clinic Foundation
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Shreveport, Louisiana, Förenta staterna, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Förenta staterna, 21229
- St. Agnes Cancer Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
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Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Clinic Medical Center - Burlington
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Worcester, Massachusetts, Förenta staterna, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Flint, Michigan, Förenta staterna, 48532
- Great Lakes Cancer Institute - McLaren
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota Cancer Center
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Mississippi
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Tupelo, Mississippi, Förenta staterna, 38801
- Digestive Health Specialists, P.A.
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Missouri
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Columbia, Missouri, Förenta staterna, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68114-4199
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
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Omaha, Nebraska, Förenta staterna, 68131-2197
- Cancer Center at Creighton University Medical Center
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New York
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New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Förenta staterna, 28204
- Presbyterian Hospital
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Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Akron, Ohio, Förenta staterna, 44302
- Akron General's McDowell Cancer Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73112
- Integris Oncology Services
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Tulsa, Oklahoma, Förenta staterna, 74136
- Natalie Warren Bryant Cancer Center
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Pennsylvania
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Abington, Pennsylvania, Förenta staterna, 19001
- Abington Memorial Hospital
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Philadelphia, Pennsylvania, Förenta staterna, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC Cancer Center at Magee-Womens Hospital
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37404-3285
- Sarah Cannon Cancer Center at Parkridge Medical Center
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Memphis, Tennessee, Förenta staterna, 38120
- Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
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Nashville, Tennessee, Förenta staterna, 37236
- Baptist Hospital
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Nashville, Tennessee, Förenta staterna, 37232-6860
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75246
- Baylor University Medical Center
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Dallas, Texas, Förenta staterna, 75231
- Presbyterian Hospital of Dallas
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Houston, Texas, Förenta staterna, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Houston, Texas, Förenta staterna, 77030
- Methodist Hospital
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Utah
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Salt Lake City, Utah, Förenta staterna, 84132
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, Förenta staterna, 05401
- Fletcher Allen Health Care - Medical Center Campus
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Virginia
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Fairfax, Virginia, Förenta staterna, 22033
- Inova Fair Oaks Hospital
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Falls Church, Virginia, Förenta staterna, 22042-3300
- INOVA Fairfax Hospital
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Richmond, Virginia, Förenta staterna, 23298-0037
- Massey Cancer Center at Virginia Commonwealth University
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Washington
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Spokane, Washington, Förenta staterna, 99210-0248
- Deaconess Medical Center
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Spokane, Washington, Förenta staterna, 99204
- Sacred Heart Medical Center
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Spokane, Washington, Förenta staterna, 99204
- Associated Surgeons P.S.
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Spokane, Washington, Förenta staterna, 99208
- Providence Cancer Center at Holy Family Hospital
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Wisconsin
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Appleton, Wisconsin, Förenta staterna, 54911
- Appleton Medical Center
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Appleton, Wisconsin, Förenta staterna, 54911-3454
- Fox Valley Surgical Associates at Appleton Medical Center
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Madison, Wisconsin, Förenta staterna, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Froedtert Memorial Lutheran Hospital
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Ontario
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Thunder Bay, Ontario, Kanada, P7B 6V4
- Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Kanada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
DISEASE CHARACTERISTICS:
- Diagnosis of stage I-III adenocarcinoma of the colon or rectum
Must have undergone an initial curative resection within the past year
- No colon or rectal cancer resection that does not allow for definitive T or N staging
- No initial post-surgical surveillance colonoscopy prior to study entry
- Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry
- No personal or family history of familial adenomatous polyposis
- No recurrent colorectal cancer
PATIENT CHARACTERISTICS:
Age
- 18 to 49 at first diagnosis
Other
- Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance
- No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer
- No evidence of recurrence of other prior malignancy
PRIOR CONCURRENT THERAPY:
Radiotherapy
- No prior pelvic radiotherapy for rectal cancer
- No concurrent preoperative pelvic radiotherapy for rectal cancer
Surgery
- See Disease Characteristics
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1
Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline. The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance. Patients may be referred for genetic counseling. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
total överlevnad
Tidsram: Upp till 2 år
|
Upp till 2 år
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Jose G. Guillem, MD, Memorial Sloan Kettering Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACOSOG-Z0190
- CDR0000069465 (Registeridentifierare: NCI Physician Data Query)
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