Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01062035
First received: February 2, 2010
Last updated: June 24, 2014
Last verified: June 2014

February 2, 2010
June 24, 2014
January 2010
September 2013   (final data collection date for primary outcome measure)
Telomere length are shorter in individuals with colon polyps. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062035 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

The aim of this study is to develop a blood test to determine which patients are at risk for pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The long-term goal of this project is to decrease deaths from colon cancer by using a blood test to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.

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

  1. Develop a DNA and data repository from individuals with advanced colon polyps (ACPs) and controls
  2. Confirm that individuals 50 to 60 years of age with ACPs tend to have shorter peripheral blood lymphocyte (PBL) telomeres than those without ACPs
  3. 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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

The only specimens obtained will be blood for PBL DNA. For all subjects two 10 cc EDTA tubes will be obtained and processed into DNA.

Non-Probability Sample

Most subjects will be recruited at the time of a clinic visit in primary care, community internal medicine, executive international physicals, and/or during a pre-colonoscopy visit in the GI Department or GI Laboratory. The ACP subjects will be identified primarily from those referred for ACP removal (EMR) and secondarily from those having screening colonoscopy.

Colonic Polyp
Not Provided
  • ACP (advanced colon polyp) Group
    Between the ages of 50 and 60 years old and have an ACP (advanced colon polyp)
  • Control Group
    Individuals between the ages of 50 and 60 years old who have had a negative screening colonoscopy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01062035
09-000131
No
Douglas L. Riegert-Johnson, M.D., Mayo Clinic Jacksonville
Mayo Clinic
Not Provided
Principal Investigator: Douglas L Riegert-Johnson, M.D. Mayo Clinic
Mayo Clinic
June 2014

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