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

Vanderbilt Hereditary Colorectal Cancer Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00675636
Enrollment
730
Registered
2008-05-09
Start date
2007-01-31
Completion date
2017-06-30
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Hereditary Non-polyposis Colon Cancer, Precancerous Condition

Keywords

colon cancer, hereditary non-polyposis colon cancer, rectal cancer, familial adenomatous polyposis

Brief summary

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.

Detailed 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.

Interventions

OTHERstudy of socioeconomic and demographic variables

database, no intervention

PROCEDUREevaluation of cancer risk factors

database, no intervention

PROCEDUREstudy of high risk factors

database, no intervention

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of patients at high risk of developing hereditary colorectal cancercontinuous data collectionDatabase will continue indefinitely with IRB approval and investigator support

Secondary

MeasureTime frame
Establishment of a tissue and data repositorycontinuous data collection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026