Genetic Study of Young Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00044967
First received: September 6, 2002
Last updated: February 6, 2009
Last verified: October 2004
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

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
Criteria

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

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

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:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior pelvic radiotherapy for rectal cancer
  • No concurrent preoperative pelvic radiotherapy for rectal cancer

Surgery

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044967

  Hide Study Locations
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
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-100277
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Surgical Oncology of Northeast Georgia
Gainesville, Georgia, United States, 30501
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Rush Copley Medical Center
Aurora, Illinois, United States, 60504-4206
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
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
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Sarah Cannon Cancer Center at Parkridge Medical Center
Chattanooga, Tennessee, United States, 37404-3285
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States, 38120
Baptist Hospital
Nashville, Tennessee, United States, 37236
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
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Methodist Hospital
Houston, Texas, United States, 77030
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
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-7375
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
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
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Jose G. Guillem, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00044967     History of Changes
Other Study ID Numbers: CDR0000069465, ACOSOG-Z0190
Study First Received: September 6, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Microsatellite Instability
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genomic Instability
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014