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

Colonic Polyp Clinical Trial

Official title:

Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062035
• Other study ID #: 09-000131
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: June 24, 2014
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length are shorter in individuals with colon polyps.		2 years	No