Genetic Study in Patients With Stage II or Stage III Colon Cancer - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI) National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003833

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	Procedure: DNA stability analysis Procedure: gene mapping

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

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)

National Cancer Institute of Canada

Investigators

Study Chair:	Richard M. Goldberg, MD	Mayo Clinic
Study Chair:	Lois Shepherd, MD	National Cancer Institute of Canada

More Information

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

Study ID Numbers:	CDR0000066990, NCCTG-984654, CAN-NCIC-CO9PATH
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003833
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

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases

Adenocarcinoma
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009