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Hereditary Colorectal and Associated Tumor Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00633607
Recruitment Status : Recruiting
First Posted : March 12, 2008
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Lynch Syndrome FAP Hereditary Diffuse Gastric Cancer Juvenile Polyposis Syndrome Peutz-Jeghers Syndrome Other: Research Registry

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Family-Based
Time Perspective: Other
Official Title: Hereditary Colorectal and Associated Tumor Registry Study
Study Start Date : April 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. [ Time Frame: 1-N/A (up to 8 years) ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, and extracted DNA are stored for potential future studies.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects are recruited from our Hereditary GI clinic.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633607

Contact: Randall E Brand, MD 412-623-3105 brandre@upmc.edu
Contact: Beth Dudley, MS, MPH, CGC 412-623-3105 dudleyre@upmc.edu

United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Randall E. Brand, MD    412-623-3105    brandre@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Randall E Brand, MD University of Pittsburgh
More Information

Responsible Party: Randall Brand, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00633607     History of Changes
Other Study ID Numbers: 04-112
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Peutz-Jeghers Syndrome
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Pigmentation Disorders
Skin Diseases