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Hereditary Colorectal and Associated Tumor Registry Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00633607
First received: March 3, 2008
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
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 Intervention
Lynch Syndrome
FAP
Hereditary Diffuse Gastric Cancer
Juvenile Polyposis Syndrome
Peutz-Jeghers Syndrome
Other: Research Registry

Study Type: Observational
Study Design: Observational Model: Family-Based
Official Title: Hereditary Colorectal and Associated Tumor Registry Study

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Research Registry
    Information regarding medical and family history is stored in the registry to be used for potential future studies
  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633607

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

Locations
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
Investigators
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 
Study First Received: March 3, 2008
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 09, 2016