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Genetic Study of Young Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes
  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:

U.S. FDA Resources

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

  Show 73 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Jose G. Guillem, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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 May 23, 2013