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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

March 3, 2008
January 14, 2016
April 2012
December 2020   (final data collection date for primary outcome measure)
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 ]
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. [ Time Frame: 1-N/A ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633607 on ClinicalTrials.gov Archive Site
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Hereditary Colorectal and Associated Tumor Registry Study
Hereditary Colorectal and Associated Tumor Registry Study
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.
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Observational
Observational Model: Family-Based
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Retention:   Samples With DNA
Description:
Serum, plasma, and extracted DNA are stored for potential future studies.
Non-Probability Sample
Potential research subjects are recruited from our Hereditary GI clinic.
  • Lynch Syndrome
  • FAP
  • Hereditary Diffuse Gastric Cancer
  • Juvenile Polyposis Syndrome
  • Peutz-Jeghers Syndrome
Other: Research Registry
Information regarding medical and family history is stored in the registry to be used for potential future studies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
8 Years to 100 Years   (Child, Adult, Senior)
No
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
 
NCT00633607
04-112
Yes
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Randall Brand, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Randall E Brand, MD University of Pittsburgh
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP