Genetic Study of the Prognostic Significance of Microsatellite Instability in Patients With Early Age-of-Onset Stage I-III Colorectal Cancer
Last Modified: 8/28/2008 First Published: 9/1/2002
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Genetic Study of Young Patients With Colorectal Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Genetics | Completed | 18 to 49 at first diagnosis | ACOSOG-Z0190
NCT00044967 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy - No prior pelvic radiotherapy for rectal cancer
- No concurrent preoperative pelvic radiotherapy for rectal cancer
Surgery - See Disease Characteristics
Patient Characteristics:
Age - 18 to 49 at first diagnosis
Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment A total of 3,000 patients will be accrued for this study within 6 years. 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.
Trial Contact Information
Trial Lead Organizations American College of Surgeons Oncology Group  | | | | Jose Guillem, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer | | | Trial Start Date | | 2002-05-20 | | | Trial Completion Date | | 2004-12-13 | | | Registered in ClinicalTrials.gov | | NCT00044967 1 | | | Date Submitted to PDQ | | 2002-06-03 | | | Information Last Verified | | 2004-10-18 | | | NCI Grant/Contract Number | | CA76001 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
| 1 | http://clinicaltrials.gov/ct/show/NCT00044967 |
| 
