Hereditary Colorectal Tumor Registry
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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 |
- 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) |
-
Other: Research 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.
Eligibility| 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:
- 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| Contact: Randall E. Brand, MD | 412-623-3105 | brandre@upmc.edu |
| Contact: Gail Tribble, RN, BSN | 412-647-8205 | tribbleg@upmc.edu |
| 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 | |
| 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: | June 13, 2012 |
| 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 May 22, 2013