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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. Read our disclaimer for details. Identifier: NCT00633607
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh

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

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Family-Based
Time Perspective: Other
Official Title: Hereditary Colorectal and Associated Tumor Registry Study
Study Start Date : April 2012
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
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

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 identifier (NCT number): NCT00633607

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Randall E Brand, MD University of Pittsburgh

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Responsible Party: Randall Brand, Principal Investigator, University of Pittsburgh Identifier: NCT00633607     History of Changes
Other Study ID Numbers: 04-112
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Peutz-Jeghers Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Neoplastic Syndromes, Hereditary
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Intestinal Polyposis
Pigmentation Disorders
Skin Diseases