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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:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003833
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: October 2002
History of Changes
  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
Official Title: The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 1999
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.

PROJECTED ACCRUAL: Approximately 480 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003833

  Show 59 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
Study Chair: Richard M. Goldberg, MD Mayo Clinic
Study Chair: Lois Shepherd, MD NCIC Clinical Trials Group
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003833     History of Changes
Other Study ID Numbers: CDR0000066990, NCCTG-984654, CAN-NCIC-CO9PATH
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

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

ClinicalTrials.gov processed this record on May 21, 2013