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

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ClinicalTrials.gov Identifier: NCT00003833
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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.


Condition or disease Intervention/treatment
Colorectal Cancer Genetic: DNA stability analysis Genetic: gene mapping

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 598 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer
Study Start Date : February 1999
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
Genetic: DNA stability analysis Genetic: gene mapping



Primary Outcome Measures :
  1. overall survival [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Normal and tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced colon cancer previously participating in NCCTG-914653.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003833


  Show 59 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
Study Chair: Richard M. Goldberg, MD Mayo Clinic

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003833     History of Changes
Other Study ID Numbers: NCCTG-984654
CDR0000066990 ( Registry Identifier: PDQ (Physician Data Query) )
CAN-NCIC-CO9PATH
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases