Clinical trial NCT01062035: Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)
Official title: Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyp
Keywords: Advanced colon polyp
Adenomatous colon polyp
Adenoma, villous colon polyp
Advanced colorectal adenomas
Colonic neoplasms
High grade dysplasia
Telomere blood testing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Telomere length are shorter in individuals with colon polyps.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Douglas L Riegert-Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: