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

March 3, 2008
December 5, 2013
December 2004
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00633607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Hereditary Colorectal Tumor Registry
Hereditary Colorectal Tumor Registry

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.

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.

Observational
Observational Model: Family-Based
Not Provided
Not Provided
Non-Probability Sample

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.

Colorectal Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact: Randall E. Brand, MD 412-623-3105 brandre@upmc.edu
Contact: Gail Tribble, RN, BSN 412-647-8205 tribbleg@upmc.edu
United States
 
NCT00633607
04-112
Yes
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Randall E. Brand, MD University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP