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

May 8, 2008
April 1, 2011
January 2007
April 2012   (final data collection date for primary outcome measure)
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
Identification of patients at high risk of developing hereditary colorectal cancer [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00675636 on ClinicalTrials.gov Archive Site
Establishment of a tissue and data repository [ Time Frame: continuous data collection ] [ Designated as safety issue: No ]
Establishment of a tissue and data repository [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Observational
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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

  • Colorectal Cancer
  • Hereditary Nonpolyposis Colorectal Cancer
  • Precancerous Condition
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
United States
 
NCT00675636
CDR0000587344, P30CA068485, VU-VICC-GI-0721, VU-VICC-061182
No
Paul E. Wise, MD/Director, Vanderbilt Herditary Colorectal Cancer Registry, Vanderbilt University Medical Center
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Paul Wise, MD Vanderbilt-Ingram Cancer Center
Vanderbilt University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP