Clinical trial NCT00675636: Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer
Official title: Vanderbilt Hereditary Colorectal Cancer Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Hereditary Non-polyposis Colon Cancer
Precancerous Condition
Keywords: colon cancer
hereditary non-polyposis colon cancer
rectal cancer
familial adenomatous polyposis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-09
Enrollment: 730
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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 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

Primary outcomes:
measure: Identification of patients at high risk of developing hereditary colorectal cancer
timeFrame: continuous data collection
Secondary outcomes:
measure: Establishment of a tissue and data repository
timeFrame: continuous data collection
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Paul Wise, MD
role: STUDY_CHAIR
References: