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

This study has been completed.
Sponsor:
Collaborators:
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 7, 2015
Last verified: July 2015
  Purpose

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 Intervention
Colorectal Cancer
Genetic: DNA stability analysis
Genetic: gene mapping

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Normal and tumor tissue


Enrollment: 598
Study Start Date: February 1999
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003833

  Show 59 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
NCIC Clinical Trials Group
Investigators
Study Chair: Richard M. Goldberg, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003833     History of Changes
Other Study ID Numbers: NCCTG-984654, CDR0000066990, CAN-NCIC-CO9PATH
Study First Received: November 1, 1999
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on July 29, 2015