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Clinical Significance of Genetic Markers in Colon Cancer


N/A
N/A
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Clinical Significance of Genetic Markers in Colon Cancer


OBJECTIVES:

- Determine the clinical and pathologic significance of unstable DNA elements in
colorectal cancer (tumor microsatellite instability).

- Determine the clinical and pathologic significance of loss of heterozygosity for
chromosomes 5, 8, 17, and 18 (as the primary targets) and of chromosomes 1, 14, and 22
(as the secondary targets) in colorectal cancer.

OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of
heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate
chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four
chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22).
Immunohistochemistry is used to test for the presence or absence of the genes involved in
DNA mismatch repair (hMLH1 and hMSH2).

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue up to 708 specimens.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Must have had a resectable adenocarcinoma of the colon or rectum and must have
participated in one of the following NCCTG randomized clinical trials:

- 784852: No Treatment Control Versus Levamisole Versus Levamisole Plus
Fluorouracil (5-FU)

- 794604: No Treatment Control Versus 5-FU by Portal Vein Infusion

- 794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential
Chemotherapy with Methyl CCNU and 5-FU

- 844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical
Adjuvant Treatment for Resectable Adenocarcinoma of the Colon

- 864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A
Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer
and (B) 5-FU Plus Methyl-CCNU Chemotherapy

- 874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM)
and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for
Resectable Adenocarcinoma of the Colon

- 894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and
Leucovorin as Adjuvant Treatment for Resectable Colon Cancer

- Tissue blocks from the primary colorectal cancer must have been received by the NCCTG
operations office

PATIENT CHARACTERISTICS:

Age

- Not specified

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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065549

NCT ID:

NCT00014079

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259