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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Precancerous Condition; Hereditary Non-polyposis Colon Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 730

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center - Cool Springs
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Anyone with known or suspected hereditary colorectal cancer syndrome, early age o onset of colorectal cancer (see below).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Establishment of a tissue and data repository	continuous data collection

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Paul Wise, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 8, 2008
• First Posted (Estimate): May 9, 2008

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer; familial adenomatous polyposis; hereditary non-polyposis colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; Colonic Neoplasms; Precancerous Conditions
• Other Study ID Numbers: CDR0000587344; P30CA068485 (U.S. NIH Grant/Contract); VU-VICC-GI-0721; VU-VICC-061182