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

Colorectal Cancer Clinical Trial

Official title:

Vanderbilt Hereditary Colorectal Cancer Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675636
• Other study ID #: CDR0000587344
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: August 1, 2017
• Start date: January 2007
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Non-polyposis Colon Cancer
• Precancerous Condition
• Precancerous Conditions

Intervention

Other:
• study of socioeconomic and demographic variables
database, no intervention

Procedure:
• evaluation of cancer risk factors
database, no intervention
• study of high risk factors
database, no intervention

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of patients at high risk of developing hereditary colorectal cancer	Database will continue indefinitely with IRB approval and investigator support	continuous data collection
Secondary	Establishment of a tissue and data repository		continuous data collection