A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
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.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 6 years.
Observational
N/A
Jose G. Guillem, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000069465
NCT00044967
May 2002
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Agnes Cancer Center | Baltimore, Maryland 21229 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Shands Cancer Center at the University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Baylor University Medical Center | Dallas, Texas 75246 |
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Providence Cancer Center at Holy Family Hospital | Spokane, Washington 99207 |
Cancer Center at Creighton University Medical Center | Omaha, Nebraska 68131 |
Morton Plant Hospital | Clearwater, Florida 33756 |
Baptist Hospital | Nashville, Tennessee 37236 |
Methodist Hospital | Houston, Texas 77030 |
Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin 53226 |
Providence Cancer Center | Mobile, Alabama 36608 |
Arrowhead Regional Medical Center | Colton, California 92324-1819 |
Surgical Oncology of Northeast Georgia | Gainesville, Georgia 30501 |
Great Lakes Cancer Institute - McLaren | Flint, Michigan 48532 |
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis | Memphis, Tennessee 38120 |
INOVA Fair Oaks Hospital | Fairfax, Virginia 22033 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Rush Copley Medical Center | Aurora, Illinois 60504-4206 |
Presbyterian Hospital of Dallas | Dallas, Texas 75231 |
Akron General's McDowell Cancer Center | Akron, Ohio 44302 |
Digestive Health Specialists, P.A. | Tupelo, Mississippi 38801 |
Integris Oncology Services | Oklahoma City, Oklahoma 73112 |
Sarah Cannon Cancer Center at Parkridge Medical Center | Chattanooga, Tennessee 37404-3285 |
Associated Surgeons P.S. | Spokane, Washington 99204 |
Sacred Heart Medical Center | Spokane, Washington 99204 |
Appleton Medical Center | Appleton, Wisconsin 54911 |
Fox Valley Surgical Associates at Appleton Medical Center | Appleton, Wisconsin 54911-3454 |