Genetic Markers in Patients With Colorectal Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00014079 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: July 13, 2016
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | April 10, 2001 | |||
First Posted Date | January 27, 2003 | |||
Last Update Posted Date | July 13, 2016 | |||
Study Start Date | September 1997 | |||
Actual Primary Completion Date | July 2003 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Determine the clinical and pathologic significance of unstable DNA elements [ Time Frame: Up to 5 years ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00014079 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Determine the clinical and pathologic significance of loss of heterozygosity [ Time Frame: Up to 5 years ] | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Genetic Markers in Patients With Colorectal Cancer | |||
Official Title | Clinical Significance of Genetic Markers in Colon Cancer | |||
Brief Summary | RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse. PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer. |
|||
Detailed Description | OBJECTIVES:
OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: This study will accrue up to 708 specimens. |
|||
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 have resectable adenocarcinoma of the colon or rectum and has been previously enrolled on N784852, N794604, N844652, N864751, N874651, and N894651. | |||
Condition | Colorectal Cancer | |||
Intervention |
|
|||
Study Groups/Cohorts | Group 1
DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. Interventions:
|
|||
Publications * | Ribic CM, Sargent DJ, Moore MJ, Thibodeau SN, French AJ, Goldberg RM, Hamilton SR, Laurent-Puig P, Gryfe R, Shepherd LE, Tu D, Redston M, Gallinger S. Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. N Engl J Med. 2003 Jul 17;349(3):247-57. | |||
* 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 |
675 | |||
Original Enrollment | Not Provided | |||
Actual Study Completion Date | May 2005 | |||
Actual Primary Completion Date | July 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | DISEASE CHARACTERISTICS:
|
|||
Sex/Gender |
|
|||
Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00014079 | |||
Other Study ID Numbers | NCCTG-934655 CDR0000065549 ( Registry Identifier: PDQ (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 |
|
|||
PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | July 2016 |