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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ontario
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Thunder Bay, Ontario, Canada, P7B 6V4
- Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Alabama
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Mobile, Alabama, États-Unis, 36640-0460
- Mobile Infirmary Medical Center
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Mobile, Alabama, États-Unis, 36608
- Providence Cancer Center
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California
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Colton, California, États-Unis, 92324-1819
- Arrowhead Regional Medical Center
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Duarte, California, États-Unis, 91010-3000
- City of Hope Comprehensive Cancer Center
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San Francisco, California, États-Unis, 94115
- UCSF Comprehensive Cancer Center
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Florida
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Clearwater, Florida, États-Unis, 33756
- Morton Plant Hospital
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Fort Lauderdale, Florida, États-Unis, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Gainesville, Florida, États-Unis, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Tampa, Florida, États-Unis, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Gainesville, Georgia, États-Unis, 30501
- Surgical Oncology of Northeast Georgia
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Illinois
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Arlington Heights, Illinois, États-Unis, 60005
- Northwest Community Hospital
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Aurora, Illinois, États-Unis, 60504-4206
- Rush Copley Medical Center
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, États-Unis, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Maywood, Illinois, États-Unis, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University Cancer Center
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Iowa
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Des Moines, Iowa, États-Unis, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Iowa City, Iowa, États-Unis, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Lexington, Kentucky, États-Unis, 40503-9985
- Central Baptist Hospital
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Clinic Foundation
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Shreveport, Louisiana, États-Unis, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, États-Unis, 21229
- St. Agnes Cancer Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Burlington, Massachusetts, États-Unis, 01805
- Lahey Clinic Medical Center - Burlington
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Worcester, Massachusetts, États-Unis, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Flint, Michigan, États-Unis, 48532
- Great Lakes Cancer Institute - McLaren
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota Cancer Center
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Mississippi
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Tupelo, Mississippi, États-Unis, 38801
- Digestive Health Specialists, P.A.
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Missouri
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Columbia, Missouri, États-Unis, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Saint Louis, Missouri, États-Unis, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, États-Unis, 68114-4199
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
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Omaha, Nebraska, États-Unis, 68131-2197
- Cancer Center at Creighton University Medical Center
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New York
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New York, New York, États-Unis, 10021
- Memorial Sloan-Kettering Cancer Center
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Rochester, New York, États-Unis, 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, États-Unis, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, États-Unis, 28204
- Presbyterian Hospital
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Durham, North Carolina, États-Unis, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, États-Unis, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Akron, Ohio, États-Unis, 44302
- Akron General's McDowell Cancer Center
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Taussig Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Integris Oncology Services
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Tulsa, Oklahoma, États-Unis, 74136
- Natalie Warren Bryant Cancer Center
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Pennsylvania
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Abington, Pennsylvania, États-Unis, 19001
- Abington Memorial Hospital
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Philadelphia, Pennsylvania, États-Unis, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15224
- Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, États-Unis, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, États-Unis, 15213
- UPMC Cancer Center at Magee-Womens Hospital
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404-3285
- Sarah Cannon Cancer Center at Parkridge Medical Center
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Memphis, Tennessee, États-Unis, 38120
- Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
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Nashville, Tennessee, États-Unis, 37236
- Baptist Hospital
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Nashville, Tennessee, États-Unis, 37232-6860
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Texas
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Dallas, Texas, États-Unis, 75246
- Baylor University Medical Center
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Dallas, Texas, États-Unis, 75231
- Presbyterian Hospital of Dallas
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Houston, Texas, États-Unis, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Houston, Texas, États-Unis, 77030
- Methodist Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, États-Unis, 05401
- Fletcher Allen Health Care - Medical Center Campus
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Virginia
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Fairfax, Virginia, États-Unis, 22033
- Inova Fair Oaks Hospital
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Falls Church, Virginia, États-Unis, 22042-3300
- INOVA Fairfax Hospital
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Richmond, Virginia, États-Unis, 23298-0037
- Massey Cancer Center at Virginia Commonwealth University
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Washington
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Spokane, Washington, États-Unis, 99210-0248
- Deaconess Medical Center
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Spokane, Washington, États-Unis, 99204
- Sacred Heart Medical Center
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Spokane, Washington, États-Unis, 99204
- Associated Surgeons P.S.
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Spokane, Washington, États-Unis, 99208
- Providence Cancer Center at Holy Family Hospital
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Wisconsin
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Appleton, Wisconsin, États-Unis, 54911
- Appleton Medical Center
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Appleton, Wisconsin, États-Unis, 54911-3454
- Fox Valley Surgical Associates at Appleton Medical Center
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Madison, Wisconsin, États-Unis, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, États-Unis, 53226
- Froedtert Memorial Lutheran Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
la survie globale
Délai: Jusqu'à 2 ans
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Jusqu'à 2 ans
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Jose G. Guillem, MD, Memorial Sloan Kettering Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ACOSOG-Z0190
- CDR0000069465 (Identificateur de registre: NCI Physician Data Query)
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