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

September 6, 2002
February 6, 2009
May 2002
December 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00044967 on ClinicalTrials.gov Archive Site
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Genetic Study of Young Patients With Colorectal Cancer
A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer

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.

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.

Observational
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Colorectal Cancer
Genetic: microsatellite instability analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00044967
CDR0000069465, ACOSOG-Z0190
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American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Jose G. Guillem, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP