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Hereditary Colorectal Tumor Registry


N/A
18 Years
50 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Family-Based

Outcome Measure:

Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.

Outcome Time Frame:

1-N/A

Safety Issue:

No

Principal Investigator

Randall E. Brand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

04-112

NCT ID:

NCT00633607

Start Date:

December 2004

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213