Colonic PolypNCT01062035
Study of a Screening Blood Test to Determine Patients' Potential Risk of Adenomatous or Advanced Colon Polyps (ACPs)
An observational study of Colonic Polyp, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects under 50 years of age
- Subjects over 60 years of age
- Subjects with colon polyps less than 10 mm in size
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
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.
Read the 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.
- 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
- Medical subject headings
- Colonic Polyps, Adenoma, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length are shorter in individuals with colon polyps.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Douglas L Riegert-Johnson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062035
- Sponsor's protocol ID
- 09-000131
- Status last verified
- Jun 2014
- First submitted
- 2 Feb 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Telomere Length as a Biomarker of Advanced Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT01062035
- Acronym / sponsor ID
- 09-000131
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- Subjects under 50 years of age
- Subjects over 60 years of age
- Subjects with colon polyps less than 10 mm in size
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Telomere length are shorter in individuals with colon polyps.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Related trials for Colonic Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas L Riegert-Johnson, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length are shorter in individuals with colon polyps. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.