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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01062035

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

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 Design

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 :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Telomere length are shorter in individuals with colon polyps. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.