Polyp Resection AdequacyNCT02217085
Colorectal Polyp Resection Adequacy
An observational study of Polyp Resection Adequacy, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyp Resection Adequacy
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 30 Jun 2022
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for colorectal adenomatous polyps.
Who may be able to join
- Age 40-80
Who cannot join
- Coagulopathy (international normalized ratio >2)
- Inflammatory bowel disease or other active colitides
- Polyps of index colonoscopy that were felt not to be completely resected or pedunculated
- Familial adenomatous polyposis or hereditary polyposis
- Potential hereditary cancer syndrome (Lynch Syndrome)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.
- Conditions
- Polyp Resection Adequacy
- Keywords
- Colorectal Cancer Screening, Colon Cancer Screening, Polyps, Colonoscopy
- Medical subject headings
- Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.
Measured: Between 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp Resection AdequacyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217085
- Sponsor's protocol ID
- RSA-RTSC 2014
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2014
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
- ClinicalTrials.gov ID
- NCT02217085
- Acronym / sponsor ID
- RSA-RTSC 2014
- Conditions
- Polyp Resection Adequacy
- Keywords
- Colorectal Cancer Screening, Colon Cancer Screening, Polyps, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Aug 2014 (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 purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for colorectal adenomatous polyps.
Key inclusion criteria (1 listed)
- Age 40-80
Key exclusion criteria (5 listed)
- Coagulopathy (international normalized ratio >2)
- Inflammatory bowel disease or other active colitides
- Polyps of index colonoscopy that were felt not to be completely resected or pedunculated
- Familial adenomatous polyposis or hereditary polyposis
- Potential hereditary cancer syndrome (Lynch Syndrome)
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
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
Time frame: Between 3-6 months
Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.
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 23 Aug 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polyp Resection Adequacy, run by Rush University Medical Center 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 1 inclusion and 5 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 23 Aug 2022. 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?
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins). (time frame: Between 3-6 months). 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 23 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.