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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00633607 |
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 |
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Colorectal Cancer |
Other: Research Registry |
Study Type: | Observational |
Study Design: | Family-Based |
Official Title: | Hereditary Colorectal Tumor Registry |
Estimated Enrollment: | 1000 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | 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.
Inclusion Criteria:
Exclusion Criteria
Contact: Linda M. Farkas, MD | (412) 692-2541 | farkaslm@upmc.edu |
Contact: Amy R. Schmotzer, RN, BSN | (412) 647-6205 | schmotzerar@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Linda M. Farkas, MD 412-692-2541 farkaslm@upmc.edu |
Principal Investigator: | Linda M. Farkas, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Cancer Institute ( Linda M. Farkas, MD ) |
Study ID Numbers: | 04-112 |
Study First Received: | March 3, 2008 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00633607 History of Changes |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |