Adenoma Detection Rate Improvement in Screening ColonoscopyNCT02193646
Endoscopic Size Assessment of Advanced Adenomatous Polyps
An observational study of Adenoma Detection Rate Improvement in Screening Colonoscopy, run by Rush University Medical Center at 1 site in United States.
Trial summary
The investigators are retrospectively comparing detection rates of adenomatous polyps, advanced adenomas, and size assessment of the polyps among Rush University Medical Center endoscopists. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma Detection Rate Improvement in Screening Colonoscopy
- How many people
- 1,930 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2025
- 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: Subjects undergoing screening colonoscopies at Rush University Medical Center.
Who may be able to join
- Presence of adenomatous polyps detected at endoscopy and diagnosed pathologically by tissue biopsy
- Have a colonoscopy at RUMC for screening purposes
Who cannot join
- Failure to meet inclusion criteria
- Previous diagnosis of IBD or colorectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Size Assessment of Advanced Adenomatous Polyps; Inter Observer Variations
The investigators are retrospectively comparing detection rates of adenomatous polyps, advanced adenomas, and size assessment of the polyps among Rush University Medical Center endoscopists. The investigators plan to review whether the size assessment of adenomatous polyps affected the surveillance protocols and if the location of polyps detected affected the detection rates.
Read the detailed description
The study plans to compare detection rates of adenomatous as well as the sessile serrated polyps, advanced adenomas and size assessment of the polyps among the endoscopists at the study site. In addition, the study team aims to evaluate rates of advanced neoplasia on surveillance colonoscopy based on certain features on initial colonoscopy and patient characteristics, including specific high-risk histologic features and concurrent medication usage such as aspirin. In addition, patients with at least one adenoma on surveillance colonoscopy will be identified and regarded as cases. Cases will be compared against normal surveillance colonoscopy. The Controls will be selected on a 1:1 ratio. Aspirin use will be compared between groups.
- Keywords
- Colonoscopy, Adenoma, ADR, Screening Colon Cancer
- Medical subject headings
- Adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomatous Polyp Detection Rate
Assessing for advanced adenomas (including location).
Measured: one year
Endoscopic Size Assessment Versus Pathological Size Assessment
Size of polyps at time of endoscopic procedure will be compared to the size of the same polyp by pathological assessment.
Measured: one year
Secondary outcomes (1)
Retroflexion as an indication of adenoma detection rate in colorectal cancer screening
Retroflexion is a common but not mandatory practice in colonoscopy which as not been systematically studied in terms of polyp detection. Charts will be reviewed to determine whether retroflexion was performed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startNov 2010
- Primary completionJan 2025
- Study completionJan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenoma Detection Rate Improvement in Screening ColonoscopyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Alsayid, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193646
- Sponsor's protocol ID
- ESA-2014
- Status last verified
- Jan 2025
- First submitted
- 14 Jul 2014
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van J, Alsayid M, Ma K, Vemulapalli K, Rex D, Melson J. Impact of Cold Snare vs Cold Forceps Resection of Diminutive Adenomas on Segmental Incomplete Resection Rate. Am J Gastroenterol. 2023 Aug 1;118(8):1410-1418. doi: 10.14309/ajg.0000000000002289. Epub 2023 Apr 11.
PubMed 37040556Alsayid M, Van J, Ma K, Melson J. Segmental metachronous adenoma rate as a metric for monitoring incomplete resection in a colonoscopy screening program. Gastrointest Endosc. 2021 Aug;94(2):347-354. doi: 10.1016/j.gie.2021.01.046. Epub 2021 Feb 6.
PubMed 33561485
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Size Assessment of Advanced Adenomatous Polyps; Inter Observer Variations
- ClinicalTrials.gov ID
- NCT02193646
- Acronym / sponsor ID
- ESA-2014
- Keywords
- Colonoscopy, Adenoma, ADR, Screening Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,930 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 17 Jul 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 investigators are retrospectively comparing detection rates of adenomatous polyps, advanced adenomas, and size assessment of the polyps among Rush University Medical Center endoscopists. The investigators plan to review whether the size assessment of adenomatous polyps affected the surveillance protocols and if the location of polyps detected affected the detection rates.
Detailed description
The study plans to compare detection rates of adenomatous as well as the sessile serrated polyps, advanced adenomas and size assessment of the polyps among the endoscopists at the study site. In addition, the study team aims to evaluate rates of advanced neoplasia on surveillance colonoscopy based on certain features on initial colonoscopy and patient characteristics, including specific high-risk histologic features and concurrent medication usage such as aspirin. In addition, patients with at least one adenoma on surveillance colonoscopy will be identified and regarded as cases. Cases will be compared against normal surveillance colonoscopy. The Controls will be selected on a 1:1 ratio. Aspirin use will be compared between groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing screening colonoscopies at Rush University Medical Center.
Key inclusion criteria (2 listed)
- Presence of adenomatous polyps detected at endoscopy and diagnosed pathologically by tissue biopsy
- Have a colonoscopy at RUMC for screening purposes
Key exclusion criteria (2 listed)
- Failure to meet inclusion criteria
- Previous diagnosis of IBD or colorectal cancer
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
Adenomatous Polyp Detection Rate
Time frame: one year
Assessing for advanced adenomas (including location).
Endoscopic Size Assessment Versus Pathological Size Assessment
Time frame: one year
Size of polyps at time of endoscopic procedure will be compared to the size of the same polyp by pathological assessment.
1 secondary outcome
Retroflexion as an indication of adenoma detection rate in colorectal cancer screening
Time frame: one year
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 22 Jan 2025.
- Results publication: PubMed 37040556Van J, Alsayid M, Ma K, Vemulapalli K, Rex D, Melson J. Impact of Cold Snare vs Cold Forceps Resection of Diminutive Adenomas on Segmental Incomplete Resection Rate. Am J Gastroenterol. 2023 Aug 1;118(8):1410-1418. doi: 10.14309/ajg.0000000000002289. Epub 2023 Apr 11.
- Results publication: PubMed 33561485Alsayid M, Van J, Ma K, Melson J. Segmental metachronous adenoma rate as a metric for monitoring incomplete resection in a colonoscopy screening program. Gastrointest Endosc. 2021 Aug;94(2):347-354. doi: 10.1016/j.gie.2021.01.046. Epub 2021 Feb 6.
- Segmental metachronous adenoma rate as a metric for monitoring incomplete resection in a colonoscopy screening programLink provided by the sponsor.
- Impact of Cold Snare vs Cold Forceps Resection of Diminutive Adenomas on Segmental Incomplete Resection RateLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Muhammad Alsayid, MD principal investigator
Rush University Medical Center
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 Adenoma Detection Rate Improvement in Screening Colonoscopy, 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 2 inclusion and 2 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 22 Jan 2025. 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?
Adenomatous Polyp Detection Rate (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193646, which also lists 2 linked publications.
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 22 Jan 2025.