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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
First Received: May 8, 2008   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00675636
  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 Non-Polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2)
Precancerous/Nonmalignant Condition
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors
Procedure: study of socioeconomic and demographic variables

Genetics Home Reference related topics: familial adenomatous polyposis Lynch syndrome
MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Vanderbilt Hereditary Colorectal Cancer Registry

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of patients at high risk of developing hereditary colorectal cancer [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Establishment of a tissue and data repository [ 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)
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
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
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-Ingram Cancer Center
Investigators
Study Chair: Paul Wise, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000587344, VU-VICC-GI-0721, VU-VICC-061182
Study First Received: May 8, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00675636     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2)
rectal cancer
colon cancer
hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2)
rectal cancer
familial adenomatous polyposis

Study placed in the following topic categories:
Familial Polyposis
Metabolic Diseases
Digestive System Neoplasms
Precancerous Conditions
Rectal Neoplasms
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Familial Adenomatous Polyposis
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal Cancer
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Genetic Diseases, Inborn
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Nonpolyposis Colon Cancer
Gastrointestinal Neoplasms
Metabolic Disorder
Colonic Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009