Hereditary Colorectal Tumor Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00633607
First received: March 3, 2008
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

This research registry is to capture high risk subjects and collect information regarding genetic make up in order to diagnose, treat and improve mortality in these high risk subjects. There has not been a great deal of research into early age colon cancer and this registry is a starting point for researchers here at the University of Pittsburgh Medical Center. We are hopeful that more research will arise from the Hereditary Colorectal Tumor Registry and also allow a continuum of care for patients in which the standards of care changes as our technology advances.


Condition Intervention
Colorectal Cancer
Other: Research Registry

Study Type: Observational
Study Design: Observational Model: Family-Based
Official Title: Hereditary Colorectal Tumor Registry

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. [ Time Frame: 1-N/A ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Research Registry
    If subjects agree to participate in the Hereditary Colorectal Tumor Registry their past, current and future medical record information will be placed into the research registry. This will permit research studies to be conducted on the medical record information contained within the registry.
Detailed Description:

In this registry, subjects will be asked to enroll based on their diagnosis of early onset colorectal cancer (age onset before 50 years old). Any subject who is less than 50 years of age will be asked to enroll if they have a history of colon polyps before age 50. MSI testing should be completed as standard of care before arriving in the Hereditary Colorectal Tumor Program clinic. However, if the subject has not had screening completed, he or she will have the MSI testing completed as part of their standard of care. Once MSI testing is complete and subjects meet the Bethesda / Revised Bethesda or Amsterdam Criteria (See Appendix 1), the clinical standard by which The American Gastroenterology Guidelines are accepted, the subjects will be referred to a genetic counselor. Once in contact with the genetic counselor they will be asked to participate in this registry. There will not be any retroactive or retrospective MSI/IHC testing as part of this registry.

If subjects agree to participate in the Hereditary Colorectal Tumor Registry their past, current and future medical record information will be placed into the research registry. This will permit research studies to be conducted on the medical record information contained within the registry. Subjects are being asked to allow us to contact them if one of our researchers determines, through review of medical record information contained in the research registry that subjects are eligible for participation in a future research study directed at the study of genetic colorectal cancer. Please note that if subjects qualify for any future research studies, they will be asked to sign a separate consent form that outlines in detail the nature of this research study, including its potential risks and benefits.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential research subjects are first identified by their primary doctor/clinical team.

First Degree Relatives A Letter of Introduction will be supplied to the participant to give to first-degree relatives. If the subject's first degree relative is interested in participation in the Hereditary Colorectal Tumor Registry, he/she will be provided with the Letter of Introduction. The first degree relative must sign the Letter of Introduction and send it back via self-addressed stamped envelope supplied by the initial participant to show interest in participation. The Letter of Introduction will inform the first degree relative subjects that they were referred to the Hereditary Colorectal Tumor Registry because of a shared family history of colorectal, ovarian, endometrial, gastric, biliary, renal pelvis, bladder, and or brain tumor.

Criteria

Inclusion Criteria:

  • HNPCC- RC less than the age of 50
  • Colorectal polyps less than the age of 40
  • HNPCC-RC at any age but a FDR with HNPCC-RC less than 50
  • Anyone with MSI positive high or Immunohistochemistry - for hMLH1, hSH2, hSH6
  • Anyone at any age with 2 HNPCC-RC (including synchronous or metachronous CRC)
  • CRC diagnosed in at least 2 FDR or SDR relatives with HNPCC-RC regardless of age
  • Anyone who is a FDR(first degree relative) to those who meet the inclusion criteria above
  • Because some of the familial cancers involve children and standard of care involves screening of children during puberty, they will also be included but with parental consent.
  • Individuals must be able to complete all questionnaires.
  • Ability to give informed consent

Exclusion Criteria

  • Individuals who do not meet the above criteria
  • Individuals who do not desire to consent to any part of the registry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633607

Contacts
Contact: Randall E. Brand, MD 412-623-3105 brandre@upmc.edu
Contact: Gail Tribble, RN, BSN 412-647-8205 tribbleg@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Randall E. Brand, MD    412-623-3105    brandre@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Randall E. Brand, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00633607     History of Changes
Other Study ID Numbers: 04-112
Study First Received: March 3, 2008
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014