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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00675636

Collaborator

National Cancer Institute (NCI) (NIH)

730

Enrollment

Locations

125

Duration (Months)

243.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Hereditary Non-polyposis Colon Cancer Precancerous Condition	Other: study of socioeconomic and demographic variables Procedure: evaluation of cancer risk factors Procedure: study of high risk factors

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.

Study Design

Study Type:

Observational

Actual Enrollment :

730 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Vanderbilt Hereditary Colorectal Cancer Registry

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Outcome Measures

Primary Outcome Measures

Identification of patients at high risk of developing hereditary colorectal cancer [continuous data collection]
Database will continue indefinitely with IRB approval and investigator support

Secondary Outcome Measures

Establishment of a tissue and data repository [continuous data collection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838