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Genetic Study in Patients With Stage II or Stage III Colon Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003833
First received: November 1, 1999
Last updated: July 12, 2016
Last verified: July 2016

November 1, 1999
July 12, 2016
February 1999
August 2006   (final data collection date for primary outcome measure)
overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Genetic Study in Patients With Stage II or Stage III Colon Cancer
The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.

PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.

OBJECTIVES:

  • Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
  • Determine if patient prognosis is dependent on the region of 8p AI.
  • Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
  • Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.

OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Normal and tumor tissue
Non-Probability Sample
Patients with advanced colon cancer previously participating in NCCTG-914653.
Colorectal Cancer
  • Genetic: DNA stability analysis
  • Genetic: gene mapping
Normal and tumor tissue pairs
Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.
Interventions:
  • Genetic: DNA stability analysis
  • Genetic: gene mapping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
August 2006
August 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of resectable stage II or III adenocarcinoma of the colon
  • Participated in NCCTG-914653
  • DNA extracted from both normal and tumor tissue

PATIENT CHARACTERISTICS:

Age

  • Under 70
Both
up to 69 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00003833
NCCTG-984654, CDR0000066990, CAN-NCIC-CO9PATH
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)
  • NCIC Clinical Trials Group
Study Chair: Richard M. Goldberg, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

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