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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00675636
First received: May 8, 2008
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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 Intervention
Colorectal Cancer
Hereditary Nonpolyposis Colorectal Cancer
Precancerous Condition
Other: study of socioeconomic and demographic variables
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vanderbilt Hereditary Colorectal Cancer Registry

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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

Estimated Enrollment: 500
Study Start Date: January 2007
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: study of socioeconomic and demographic variables
    database, no intervention
    Procedure: evaluation of cancer risk factors
    database, no intervention
    Procedure: study of high risk factors
    database, no intervention
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675636

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Paul Wise    615-343-4612      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Paul Wise    615-343-4612      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Chair: Paul Wise, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Paul E. Wise, MD/Director, Vanderbilt Herditary Colorectal Cancer Registry, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00675636     History of Changes
Other Study ID Numbers: CDR0000587344, P30CA068485, VU-VICC-GI-0721, VU-VICC-061182
Study First Received: May 8, 2008
Last Updated: April 1, 2011
Health Authority: United States: Vanderbilt Institutional Review Board and Human Research Protection Program

Keywords provided by Vanderbilt University:
colon cancer
hereditary non-polyposis colon cancer
rectal cancer
familial adenomatous polyposis

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Precancerous Conditions
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014