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	Sponsor	Protocol IDs
No phase specified	Genetics	Completed	18 to 49 at first diagnosis	NCI	ACOSOG-Z0190 NCT00044967

Objectives

1. 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.
2. Evaluate the development of metachronous neoplasms in this patient population.
3. 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

• 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

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

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		Ph: 212-639-8278; 800-525-2225 Email: guillemj@mskcc.org

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
Date Submitted to PDQ		2002-06-03
Information Last Verified		2004-10-18
NCI Grant/Contract Number		CA76001

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