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

NCT00675636 | Completed

• 4 other identifiers: CDR0000587344P30CA068485VU-VICC-GI-0721VU-VICC-061182
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Cancer; Hereditary Non-polyposis Colon Cancer; Precancerous Condition

Keywords

colon cancer; hereditary non-polyposis colon cancer; rectal cancer; familial adenomatous polyposis

Outcome Measures

Primary Outcomes (1)

• Identification of patients at high risk of developing hereditary colorectal cancer

  Database will continue indefinitely with IRB approval and investigator support

  continuous data collection

Secondary Outcomes (1)

• Establishment of a tissue and data repository

  continuous data collection

Interventions

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

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis; Precancerous Conditions; Colonic Neoplasms; Rectal Neoplasms; Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Polyposis

Study Officials

• Paul Wise, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 9, 2008
• Study Start: January 1, 2007
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

US (3)