Hereditary Colorectal and Associated Tumor Registry Study

NCT ID: NCT00633607

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2018-01-26

Brief Summary

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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.

Detailed Description

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Conditions

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Lynch Syndrome FAP Hereditary Diffuse Gastric Cancer Juvenile Polyposis Syndrome Peutz-Jeghers Syndrome

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

OTHER

Interventions

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Research Registry

Information regarding medical and family history is stored in the registry to be used for potential future studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Randall Brand

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall E Brand, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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04-112

Identifier Type: -

Identifier Source: org_study_id

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