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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062035
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : June 26, 2014
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease
Colonic Polyp

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

  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.

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
Study Start Date : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

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.

Primary Outcome Measures :
  1. Telomere length are shorter in individuals with colon polyps. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062035

United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Douglas L Riegert-Johnson, M.D. Mayo Clinic

Responsible Party: Douglas L. Riegert-Johnson, M.D., Mayo Clinic Jacksonville Identifier: NCT01062035     History of Changes
Other Study ID Numbers: 09-000131
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Mayo Clinic:
Advanced colon polyp
Adenomatous colon polyp
Adenoma, villous colon polyp
Advanced colorectal adenomas
Colonic neoplasms
High grade dysplasia
Telomere blood testing

Additional relevant MeSH terms:
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps