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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00675636 |
RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.
Condition | Intervention |
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Colorectal Cancer Hereditary Non-Polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2) Precancerous/Nonmalignant Condition |
Procedure: evaluation of cancer risk factors Procedure: study of high risk factors Procedure: study of socioeconomic and demographic variables |
Study Type: | Observational |
Official Title: | Vanderbilt Hereditary Colorectal Cancer Registry |
Estimated Enrollment: | 500 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets any of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Paul Wise 615-343-4612 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Paul Wise 615-343-4612 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Study Chair: | Paul Wise, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000587344, VU-VICC-GI-0721, VU-VICC-061182 |
Study First Received: | May 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00675636 History of Changes |
Health Authority: | Unspecified |
colon cancer hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2) rectal cancer colon cancer |
hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2) rectal cancer familial adenomatous polyposis |
Familial Polyposis Metabolic Diseases Digestive System Neoplasms Precancerous Conditions Rectal Neoplasms Adenomatous Polyposis Coli Gastrointestinal Diseases Familial Adenomatous Polyposis Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal Cancer Neoplastic Syndromes, Hereditary Digestive System Diseases Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Hereditary Nonpolyposis Colon Cancer Gastrointestinal Neoplasms Metabolic Disorder Colonic Neoplasms Colorectal Neoplasms |
Metabolic Diseases Digestive System Neoplasms Precancerous Conditions Gastrointestinal Diseases DNA Repair-Deficiency Disorders Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Neoplastic Syndromes, Hereditary Neoplasms by Site Digestive System Diseases Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |