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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00044967 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Genetic: microsatellite instability analysis |
| Study Type: | Observational |
| Official Title: | A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer |
| Study Start Date: | May 2002 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone an initial curative resection within the past year
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36640-0460 | |
| Providence Cancer Center | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| Arrowhead Regional Medical Center | |
| Colton, California, United States, 92324-1819 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| Shands Cancer Center at the University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-100277 | |
| United States, Georgia | |
| Surgical Oncology of Northeast Georgia | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush Copley Medical Center | |
| Aurora, Illinois, United States, 60504-4206 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503-9985 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| St. Agnes Cancer Center | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Lahey Clinic Medical Center - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Great Lakes Cancer Institute - McLaren | |
| Flint, Michigan, United States, 48532 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Digestive Health Specialists, P.A. | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Cancer Center at Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Akron General's McDowell Cancer Center | |
| Akron, Ohio, United States, 44302 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Integris Oncology Services | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Natalie Warren Bryant Cancer Center | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| UPMC Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Tennessee | |
| Baptist Cancer Institute at Baptist Memorial Hospital - Memphis | |
| Memphis, Tennessee, United States, 38120 | |
| Baptist Hospital | |
| Nashville, Tennessee, United States, 37236 | |
| Sarah Cannon Cancer Center at Parkridge Medical Center | |
| Chattanooga, Tennessee, United States, 37404-3285 | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6860 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Presbyterian Hospital of Dallas | |
| Dallas, Texas, United States, 75231 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Vermont | |
| Fletcher Allen Health Care - Medical Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| INOVA Fair Oaks Hospital | |
| Fairfax, Virginia, United States, 22033 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Massey Cancer Center at Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| Associated Surgeons P.S. | |
| Spokane, Washington, United States, 99204 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Providence Cancer Center at Holy Family Hospital | |
| Spokane, Washington, United States, 99208 | |
| Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Appleton Medical Center | |
| Appleton, Wisconsin, United States, 54911 | |
| Fox Valley Surgical Associates at Appleton Medical Center | |
| Appleton, Wisconsin, United States, 54911-3454 | |
| Froedtert Memorial Lutheran Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-7375 | |
| Canada, Ontario | |
| Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Study Chair: | Jose G. Guillem, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000069465, ACOSOG-Z0190 |
| Study First Received: | September 6, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044967 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I colon cancer stage II colon cancer stage III colon cancer stage I rectal cancer |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Digestive System Neoplasms Microsatellite Instability Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Genomic Instability Gastrointestinal Neoplasms Colorectal Neoplasms |
