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Home > "G" Clinical Trials Conditions > Genetic Study of Patients and Families With a History of Colorectal Cancer  Genetic Study of Patients and Families With a History of Colorectal Cancer
Genetic Study of Patients and Families With a History of Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer,Gastrointestinal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Determination of genetic markers for colorectal cancer may help doctors to identify patients who are at risk. PURPOSE: Genetic testing study of patients and families with a history of colorectal cancer to identify patients who are at risk of developing colorectal cancer.
Details: OBJECTIVES: I. Select patients with colon cancer and families at high-risk for colon cancer and collect leukocyte DNA, immortalized cell lines, plasma, and tumor specimens from these individuals and from control individuals. II. Develop patient education, counseling, and follow up plans for these individuals. III. Compare the frequency of defective DNA mismatch repair in individuals with familial colon cancer versus all colon cancers by using antibodies to the hMSH2 and hMLH1 protein products. PROTOCOL OUTLINE: This is a multicenter study. Patients, family members, and control individuals complete an extended telephone interview, an extended personal interview, and an epidemiological survey, and contribute a blood specimen. Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products. Patients may be contacted periodically (about every 3 years) to update information about health, health practices, and family history. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: At least 500-600 families (approximately 1500 patients) and the same number of matched controls will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Primary colorectal cancer and participating in one of the following NCCTG protocols: NCCTG-784852: No Treatment Control Versus Levamisole Versus Levamisole Plus 5-Fluorouracil; NCCTG-794604: No Treatment Control Versus 5-FU by Portal Vein Infusion; NCCTG-794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU; NCCTG-844652: An Intergroup Study - An Evaluation of Levamisole Alone or Levamisole Plus 5-Fluorouracil as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon; NCCTG-864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controlled Evaluation of (A) Protracted-Infusion-5-Fluorouracil (5-FU) as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy; NCCTG-874651: M/N - A Controlled Evaluation of Recombinant Interferon-Gamma (IFN-GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon; NCCTG-894651: A Controlled Phase III Evaluation of 5-Fluorouracil with Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer; NCCTG-914653: A Phase III Evaluation of High-Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer - Adequate tissue for review OR Families of patients meeting the above criteria OR Colon cancer patient and population controls not in a high-risk family OR Spouse of a high-risk colon cancer patient --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Not specified - Performance status: See Disease Characteristics - Life expectancy: See Disease Characteristics - Hematopoietic: See Disease Characteristics - Hepatic: See Disease Characteristics - Renal: See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NoralaneLindor, Study Chair, North Central Cancer Treatment Group
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Additional Information:
Study ID Numbers: CDR0000066737; NCCTG-974655
Study Start Date: July 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003648
Other Gastrointestinal Cancer Studies:
1. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
2. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
3. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
4. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
5. Curcumin for the Prevention of Colon Cancer
Related Studies:
Other Gastrointestinal Cancer Clinical Trials
Other Saskatchewan Clinical Trials
Other Regina Clinical Trials
Genetic Study of Patients and Families With a History of Colorectal Cancer
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