Viewing Study NCT01062035


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Study NCT ID: NCT01062035
Status: COMPLETED
Last Update Posted: 2014-06-26
First Post: 2010-02-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)
Sponsor: Mayo Clinic
Organization:

Study Overview

Official Title: Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
Status: COMPLETED
Status Verified Date: 2014-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: