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Trial record 21 of 54 for:    colon cancer | ( Map: Mississippi, United States )

Genetic Study of Young Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00044967
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date September 6, 2002
First Posted Date January 27, 2003
Last Update Posted Date July 6, 2016
Study Start Date May 2002
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2015)
overall survival [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00044967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Study of Young Patients With Colorectal Cancer
Official Title A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer
Brief 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.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with adenocarcinoma of the colon or rectum.
Condition Colorectal Cancer
Intervention Genetic: microsatellite instability analysis
Study Groups/Cohorts Group 1

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.

Intervention: Genetic: microsatellite instability analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2015)
651
Original Enrollment Not Provided
Actual Study Completion Date December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00044967
Other Study ID Numbers ACOSOG-Z0190
ACOSOG-Z0190
CDR0000069465 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Jose G. Guillem, MD Memorial Sloan Kettering Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016