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
  Purpose

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
Colonic Polyp

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Telomere length are shorter in individuals with colon polyps. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.


Enrollment: 72
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062035

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

No publications provided

Responsible Party: Douglas L. Riegert-Johnson, M.D., Mayo Clinic Jacksonville
ClinicalTrials.gov Identifier: NCT01062035     History of Changes
Other Study ID Numbers: 09-000131
Study First Received: February 2, 2010
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

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
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 14, 2014