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Hereditary Colorectal and Associated Tumor Registry Study

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ClinicalTrials.gov Identifier: NCT00633607
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Randall Brand, University of Pittsburgh

March 3, 2008
March 12, 2008
February 16, 2018
April 2012
January 26, 2018   (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) ]
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. [ Time Frame: 1-N/A ]
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.
Not Provided
Observational
Observational Model: Family-Based
Time Perspective: Other
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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.
 
Completed
114
1000
January 26, 2018
January 26, 2018   (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
Sexes Eligible for Study: All
8 Years to 100 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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
February 2018