Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Colorectal Cancer Hereditary Nonpolyposis Colorectal Cancer Precancerous Condition |
Other: study of socioeconomic and demographic variables Procedure: evaluation of cancer risk factors Procedure: study of high risk factors |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Vanderbilt Hereditary Colorectal Cancer Registry |
- Identification of patients at high risk of developing hereditary colorectal cancer [ Time Frame: continuous data collection ] [ Designated as safety issue: No ]Database will continue indefinitely with IRB approval and investigator support
- Establishment of a tissue and data repository [ Time Frame: continuous data collection ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Other: study of socioeconomic and demographic variables
OBJECTIVES:
Primary
- To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
Secondary
- To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Anyone with known or suspected hereditary colorectal cancer syndrome, early age o onset of colorectal cancer (see below).
DISEASE CHARACTERISTICS:
Meets any of the following criteria:
- Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
- Patients who meet Amsterdam I, II, or Bethesda criteria
- Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
- Patients diagnosed with colorectal cancer at < 50 years old
- Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Paul E. Wise, MD/Director, Vanderbilt Herditary Colorectal Cancer Registry, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00675636 History of Changes |
| Other Study ID Numbers: | CDR0000587344, P30CA068485, VU-VICC-GI-0721, VU-VICC-061182 |
| Study First Received: | May 8, 2008 |
| Last Updated: | April 1, 2011 |
| Health Authority: | United States: Vanderbilt Institutional Review Board and Human Research Protection Program |
Keywords provided by Vanderbilt University:
|
colon cancer hereditary non-polyposis colon cancer rectal cancer familial adenomatous polyposis |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Precancerous Conditions Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013