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

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.

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Key information

Conditions

Colonic Polyp Adenoma Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Telomere length are shorter in individuals with colon polyps.

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Feb 4, 2010
Registry last updated: Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed