- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062035
Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)
Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
Study Overview
Status
Conditions
Detailed Description
Telomeres are the repetitive DNA sequences that cap both ends of chromosomes. Shortening of peripheral blood lymphocyte (PBL) telomeres has been associated with renal and other cancers. The investigators' preliminary data shows an association between shorter PBL telomere length and ACPs.
I. Specific Aims
- Develop a DNA and data repository from individuals with advanced colon polyps (ACPs) and controls
- Confirm that individuals 50 to 60 years of age with ACPs tend to have shorter peripheral blood lymphocyte (PBL) telomeres than those without ACPs
- Identify a potential optimal PBL telomere length cut-off to differentiate between individuals with ACPs and those without for evaluation in a larger scale study
The over reaching long term goal is to decrease disease and death from colorectal cancer (CRC) using a biomarker strategy to target colonoscopy to those at higher risk.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Advanced Colon Polyp Group (ACP):
- Must be 50 to 60 years of age with an advanced colon polyp (ACP: advanced colon polyps are those larger than 10 mm, or a colon polyp with high grade dysplasia, or a colon polyp with villous features.
Control Group (Controls):
- Must be 50 to 60 years of age and have had a negative screening colonoscopy.
- Controls will also have no history of adenomatous colorectal neoplasia.
Exclusion Criteria:
- Subjects under 50 years of age
- Subjects over 60 years of age
- Subjects with colon polyps less than 10 mm in size
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ACP (advanced colon polyp) Group
Between the ages of 50 and 60 years old and have an ACP (advanced colon polyp)
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Control Group
Individuals between the ages of 50 and 60 years old who have had a negative screening colonoscopy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Telomere length are shorter in individuals with colon polyps.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Douglas L Riegert-Johnson, M.D., Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-000131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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