Colon Cancer Clinical Trial

Genetic Study of Young Patients With Colorectal Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

651

Study ID:

NCT00044967

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 69 Locations for this study

See Locations Near You

Providence Cancer Center
Mobile Alabama, 36608, United States
Mobile Infirmary Medical Center
Mobile Alabama, 36640, United States
Arrowhead Regional Medical Center
Colton California, 92324, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville Florida, 32610, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Surgical Oncology of Northeast Georgia
Gainesville Georgia, 30501, United States
Northwest Community Hospital
Arlington Heights Illinois, 60005, United States
Rush Copley Medical Center
Aurora Illinois, 60504, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
St. Agnes Cancer Center
Baltimore Maryland, 21229, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Lahey Clinic Medical Center - Burlington
Burlington Massachusetts, 01805, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
Great Lakes Cancer Institute - McLaren
Flint Michigan, 48532, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Digestive Health Specialists, P.A.
Tupelo Mississippi, 38801, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha Nebraska, 68114, United States
Cancer Center at Creighton University Medical Center
Omaha Nebraska, 68131, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Presbyterian Hospital
Charlotte North Carolina, 28204, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Akron General's McDowell Cancer Center
Akron Ohio, 44302, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Integris Oncology Services
Oklahoma City Oklahoma, 73112, United States
Natalie Warren Bryant Cancer Center
Tulsa Oklahoma, 74136, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Sarah Cannon Cancer Center at Parkridge Medical Center
Chattanooga Tennessee, 37404, United States
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
Memphis Tennessee, 38120, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
Baptist Hospital
Nashville Tennessee, 37236, United States
Presbyterian Hospital of Dallas
Dallas Texas, 75231, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Methodist Hospital
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84132, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington Vermont, 05401, United States
INOVA Fair Oaks Hospital
Fairfax Virginia, 22033, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond Virginia, 23298, United States
Associated Surgeons P.S.
Spokane Washington, 99204, United States
Sacred Heart Medical Center
Spokane Washington, 99204, United States
Providence Cancer Center at Holy Family Hospital
Spokane Washington, 99208, United States
Deaconess Medical Center
Spokane Washington, 99210, United States
Fox Valley Surgical Associates at Appleton Medical Center
Appleton Wisconsin, 54911, United States
Appleton Medical Center
Appleton Wisconsin, 54911, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Froedtert Memorial Lutheran Hospital
Milwaukee Wisconsin, 53226, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay Ontario, P7B 6, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

651

Study ID:

NCT00044967

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider