Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

study id #: NCT00675636

condition: Colorectal Cancer, Hereditary Nonpolyposis Colorectal Cancer, Precancerous Condition

status: Completed

intervention:
Other: study of socioeconomic and demographic variables
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors

start date: January 2007

estimated completion: June 2017

last updated: August 2, 2017

phase of development: Not Available

size / enrollment: 730

study design:
Time Perspective: Prospective

study description:
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.

primary outcomes:

• 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

secondary outcomes:

• Establishment of a tissue and data repository [ Time Frame:continuous data collection ] [ Designated as safety issue:No ]

inclusion criteria:
DISEASE CHARACTERISTICS: - Meets any of the following criteria:
1. Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
2. Patients who meet Amsterdam I, II, or Bethesda criteria
3. Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
4. 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

exclusion criteria:

sponsor: Vanderbilt University

contacts:
Vanderbilt-Ingram Cancer Center
800-811-8480

investigators: Paul Wise, MD

locations: United States