Genetic Study of Familial Factors in Patients With Colon Cancer

NCT00055848 | Completed

• 2 other identifiers: CALGB-150008CDR0000271314
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer

Study Arms (1)

Group 1

Patients donate blood samples for analysis of colorectal susceptibility genes. Patients also complete a questionnaire regarding family cancer history. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. Participants do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

Genetic: cytogenetic analysis; Genetic: gene mapping; Genetic: microarray analysis

Interventions

cytogenetic analysis GENETIC

Group 1

gene mapping GENETIC

Group 1

microarray analysis GENETIC

Group 1

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.

DISEASE CHARACTERISTICS: * Diagnosis of colon cancer or polyps at age 70 or under * Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under * No history of familial adenomatous polyposis syndrome * No hereditary nonpolyposis colon cancer, according to Amsterdam criteria * No known I1370K adenomatous polyposis of the colon susceptibility variant * Enrolled on 1 of the following clinical trials: * CLB-9581 * CLB-89803 * CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible. PATIENT CHARACTERISTICS: Age * 70 and under at diagnosis Other * No significant psychiatric illness that would preclude giving informed consent * No inflammatory bowel disease (in patient or sibling)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Cytogenetic Analysis; Chromosome Mapping; Microarray Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Microchip Analytical Procedures

Study Officials

• Monica M. Bertagnolli, MD

  Dana-Farber/Brigham and Women's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: December 1, 2001
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 13, 2016

Record last verified: 2015-07

Locations

US (1)