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Vanderbilt Hereditary Colorectal Cancer Registry


N/A
N/A
N/A
Open (Enrolling)
Both
Colorectal Cancer, Hereditary Nonpolyposis Colorectal Cancer, Precancerous Condition

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Trial Information

Vanderbilt Hereditary Colorectal Cancer Registry


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Identification of patients at high risk of developing hereditary colorectal cancer

Outcome Description:

Database will continue indefinitely with IRB approval and investigator support

Outcome Time Frame:

continuous data collection

Safety Issue:

No

Principal Investigator

Paul Wise, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Vanderbilt Institutional Review Board and Human Research Protection Program

Study ID:

CDR0000587344

NCT ID:

NCT00675636

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Hereditary Nonpolyposis Colorectal Cancer
  • Precancerous Condition
  • colon cancer
  • hereditary non-polyposis colon cancer
  • rectal cancer
  • familial adenomatous polyposis
  • Colorectal Neoplasms
  • Precancerous Conditions
  • Colorectal Neoplasms, Hereditary Nonpolyposis

Name

Location

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