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NCT00633607 Clinical Trial

Hereditary Colorectal and Associated Tumor Registry Study

Lynch Syndrome Clinical Trial

Official title:
Hereditary Colorectal and Associated Tumor Registry Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00633607
Other study ID # 04-112
Secondary ID
Status Completed
Phase N/A
First received March 3, 2008
Last updated February 15, 2018
Start date April 2012
Est. completion date January 26, 2018

Study information
Verified date February 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date January 26, 2018
Est. primary completion date January 26, 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 100 Years
Eligibility Inclusion Criteria:

- Identified gene mutation

- Personal history of colorectal cancer diagnosed = 50

- Personal history of cancer with tumor studies suggestive of Lynch syndrome

- Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)

- Personal history of one of the above cancers and a family history of one or more of the above cancers

- Personal or family history of diffuse gastric cancer

- From a known genetic predisposition family

- Personal history of > 10 colon adenomas (cumulative over a lifetime)

- Personal history of any number of hamartomatous polyps

- Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid

Exclusion critera:

- Individuals under the age of 8

- Individuals who cannot travel to Pittsburgh for in-person enrollment

- Individuals who cannot provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Research Registry
Information regarding medical and family history is stored in the registry to be used for potential future studies

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. 1-N/A (up to 8 years)
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