Hereditary Colorectal Tumor Registry
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
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.
1-N/A
No
Randall E. Brand, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
04-112
NCT00633607
December 2004
December 2014
Name | Location |
---|---|
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |