Spots Global Cancer Trial Database for Genetic Study of Young Patients With Colorectal Cancer
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Trial Identification
Brief Title: Genetic Study of Young Patients With Colorectal Cancer
Official Title: A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
Study ID: NCT00044967
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Cancer Center, Mobile, Alabama, United States
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Arrowhead Regional Medical Center, Colton, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Morton Plant Hospital, Clearwater, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Surgical Oncology of Northeast Georgia, Gainesville, Georgia, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Rush Copley Medical Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
St. Agnes Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Lahey Clinic Medical Center - Burlington, Burlington, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Great Lakes Cancer Institute - McLaren, Flint, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Digestive Health Specialists, P.A., Tupelo, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States
Cancer Center at Creighton University Medical Center, Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Akron General's McDowell Cancer Center, Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Integris Oncology Services, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center at Parkridge Medical Center, Chattanooga, Tennessee, United States
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
Baptist Hospital, Nashville, Tennessee, United States
Presbyterian Hospital of Dallas, Dallas, Texas, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Methodist Hospital, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
INOVA Fair Oaks Hospital, Fairfax, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
Associated Surgeons P.S., Spokane, Washington, United States
Sacred Heart Medical Center, Spokane, Washington, United States
Providence Cancer Center at Holy Family Hospital, Spokane, Washington, United States
Deaconess Medical Center, Spokane, Washington, United States
Fox Valley Surgical Associates at Appleton Medical Center, Appleton, Wisconsin, United States
Appleton Medical Center, Appleton, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Contact Details
Name: Jose G. Guillem, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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