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OpenTrials
Completed

NCT Number: NCT00675636

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

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.

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Key information

Conditions

Colorectal Cancer Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Hereditary Non-polyposis Colon Cancer Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Precancerous Condition Precancerous Conditions Rectal Diseases Rectal Neoplasms

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

study of socioeconomic and demographic variables

Other

database, no intervention

evaluation of cancer risk factors

Procedure

database, no intervention

study of high risk factors

Procedure

database, no intervention

Primary outcomes

  1. Identification of patients at high risk of developing hereditary colorectal cancer

    Time frame: continuous data collection

    Database will continue indefinitely with IRB approval and investigator support

Secondary outcomes

  1. Establishment of a tissue and data repository

    Time frame: continuous data collection

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Vanderbilt Hereditary Colorectal Cancer Registry

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
May 9, 2008
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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