Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer
NCT ID: NCT00675636
Last Updated: 2017-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
730 participants
OBSERVATIONAL
2007-01-31
2017-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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study of socioeconomic and demographic variables
database, no intervention
evaluation of cancer risk factors
database, no intervention
study of high risk factors
database, no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
100 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Molly Cone
Assistant Professor
Principal Investigators
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Paul Wise, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-GI-0721
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-061182
Identifier Type: -
Identifier Source: secondary_id
CDR0000587344
Identifier Type: -
Identifier Source: org_study_id
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