Colorectal PolypsCOLO-PREDICTNCT07424391
COLO-PREDICT: Digital Training and Optical Diagnosis of Colorectal Polyps
An observational study of Colorectal Polyps, run by Clinique Paris-Bercy at 1 site in France.
Trial summary
Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Digital Training Program (Colo-ID)
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing colonoscopy in routine clinical practice at Clinique Paris-Bercy, in whom at least one colorectal polyp is detected and optically characterized by participating endoscopists. The study evaluates optical histology prediction performance before and after implementation of the Colo-ID digital training program. Histopathological analysis of resected polyps serves as the reference standard when applicable.
Who may be able to join
- Adults aged ≥18 years
- Patients undergoing colonoscopy in routine clinical practice at the participating center
- At least one colorectal polyp detected during colonoscopy
- Optical histology prediction recorded during the procedure
- Histopathological analysis available for resected polyps (reference standard)
Who cannot join
- Patients aged <18 years
- Refusal/opposition to use of data (if applicable under local regulations)
- Missing key study data (e.g., no recorded optical prediction or no histopathology result)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Coralie Declerck, Ms. contact
France1 site, 1 recruiting
- Recruiting
Clinique Paris-Bercy
Charenton-le-Pont, Val de Marne, 94220
David Karsenti, MD, 0143967850, karsenti.paris@gmail.com
karsenti.paris@gmail.com
About this study
Official title: Impact of a Digital Training Program (Colo-ID) on Optical Histologic Prediction and Management of Colorectal Polyps: A Prospective Study
Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice.
COLO-PREDICT is a prospective, single-center, observational study designed to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histology prediction of colorectal polyps in real-life clinical practice.
Read more
All consecutive adult patients undergoing colonoscopy with at least one detected polyp will be included. Optical prediction of polyp histology will be recorded during the procedure. All polyps will be resected and sent for histopathological analysis according to standard practice. No modification of patient management will occur as part of the study.
The primary objective is to assess the concordance between optical prediction and histopathology before and after implementation of the digital training program. Secondary objectives include evaluation of prediction performance according to polyp characteristics and assessment of potential implications for clinical practice.
Read the detailed description
Colorectal cancer (CRC) prevention depends on the detection and removal of precursor lesions during colonoscopy. Optical diagnosis of colorectal polyps using enhanced imaging technologies has been proposed to improve procedural efficiency and to potentially support management strategies such as resect-and-discard for diminutive lesions. However, variability in optical characterization accuracy remains a major limitation in routine practice.
COLO-PREDICT is a prospective, single-center, observational study conducted in real-life clinical practice. The study aims to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histologic prediction of colorectal polyps.
Adult patients undergoing colonoscopy with at least one detected polyp will be consecutively included. During each procedure, the endoscopist will record an optical prediction of polyp histology based on standard classification systems and routine imaging modalities. All polyps will be resected and submitted for histopathological examination in accordance with current standard of care. No modification of patient management, surveillance interval, or therapeutic strategy will be implemented as part of the study.
The digital training program consists of a structured educational intervention focused on optical characterization principles, image-based training, and performance assessment in a simulated environment. The study evaluates optical prediction performance before and after implementation of this training program in routine practice.
The primary endpoint is the rate of concordance between optical histologic prediction and final histopathology. Secondary endpoints include diagnostic performance parameters (sensitivity, specificity, positive predictive value, negative predictive value), performance according to polyp size and location, and assessment of potential implications for clinical practice efficiency.
Data will be collected prospectively and analyzed using appropriate statistical methods to compare performance before and after training. The study is conducted in accordance with ethical and regulatory requirements and does not introduce additional risk for patients, as all clinical decisions follow standard practice.
- Conditions
- Colorectal Polyps
- Being tested
- Digital Training Program (Colo-ID)
- Keywords
- Optical diagnosis, Colonoscopy, Histologic prediction, Resect-and-discard strategy, Digital training, Endoscopic imaging, Polyp characterization, Real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Training Program (Colo-ID)Other
Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Colonoscopy Cohort | Adult patients undergoing colonoscopy with at least one detected colorectal polyp. Optical histology prediction is recorded during routine clinical practice. All polyps are resected and sent for histopathological analysis according to standard care. No modification of patient management is performed as part of the study. Receives: Other: Digital Training Program (Colo-ID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program
Difference in overall accuracy of optical histologic prediction of colorectal polyps (agreement with final histopathology) between the pre-training period and the post-training period following implementation of the Colo-ID training program in routine clinical practice.
Measured: Pre-training period and post-training period between February 2026 and June 2026.
Secondary outcomes (6)
Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies
Proportion of detected polyps meeting guideline-based criteria for implementation of resect-and-discard or diagnose-and-leave strategies.
Measured: From February 2026 to June 2026.
Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard
Rate of advanced histologic features among polyps classified as eligible for resect-and-discard or diagnose-and-leave strategies based on optical prediction.
Measured: From February 2026 to June 2026.
Inter-Operator Variability in Optical Prediction Accuracy
Comparison of optical prediction accuracy across participating endoscopists and assessment of potential reduction in variability after training.
Measured: Pre- and post-training periods between February 2026 and June 2026.
Individual and Collective Performance Evolution After Training
Change in individual and group-level optical prediction accuracy associated with routine use of the Colo-ID training tool.
Measured: Pre- and post-training periods between February 2026 and June 2026.
Estimated Potential Cost and Environmental Savings Associated With Resect-and-Discard and Diagnose-and-Leave Strategies Eligibility
Estimated potential reduction in histopathology analyses and associated costs and carbon footprint, calculated by multiplying the number of polyps deemed eligible for discard/leave by average unit cost and average unit environmental impact per pathology analysis.
Measured: End of study analysis (June 2026).
Change in Questionnaire Score Assessing Confidence, Knowledge, and Readiness to Implement Resect-and-Discard and Diagnose-and-Leave Strategies
Change in pre- vs post-training questionnaire responses using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The questionnaire includes identical items before and after training and covers: (1) diagnostic confidence, (2) perceived ability to identify polyps eligible for resect-and-discard and diagnose-and-leave, (3) knowledge/adhesion to European Society of Gastrointestinal Endoscopy (ESGE) recommendations, and (4) perceived usefulness of the training program. Analyses will include the key item assessing readiness to implement Resect-and-Discard and Diagnose-and-Leave strategies in routine practice.
Measured: Pre-training and post-training (within February 2026 to June 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start9 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Paris-Bercy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David D Karsenti, Principal investigator, Centre d'Explorations Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424391
- Sponsor's protocol ID
- COLO-PREDICT
- Acronym
- COLO-PREDICT
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available upon reasonable request to the corresponding investigator, subject to institutional approval and data use agreement.
Publications
Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.
PubMed 21353837Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
PubMed 32572858Houwen BBSL, Hassan C, Coupe VMH, Greuter MJE, Hazewinkel Y, Vleugels JLA, Antonelli G, Bustamante-Balen M, Coron E, Cortas GA, Dinis-Ribeiro M, Dobru DE, East JE, Iacucci M, Jover R, Kuvaev R, Neumann H, Pellise M, Puig I, Rutter MD, Saunders B, Tate DJ, Mori Y, Longcroft-Wheaton G, Bisschops R, Dekker E. Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2022 Jan;54(1):88-99. doi: 10.1055/a-1689-5130. Epub 2021 Dec 6.
PubMed 34872120
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Digital Training Program (Colo-ID) on Optical Histologic Prediction and Management of Colorectal Polyps: A Prospective Study
- ClinicalTrials.gov ID
- NCT07424391
- Acronym / sponsor ID
- COLO-PREDICT / COLO-PREDICT
- Conditions
- Colorectal Polyps
- Keywords
- Optical diagnosis, Colonoscopy, Histologic prediction, Resect-and-discard strategy, Digital training, Endoscopic imaging, Polyp characterization, Real-world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Clinique Paris-BercyUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- 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.
Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice.
COLO-PREDICT is a prospective, single-center, observational study designed to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histology prediction of colorectal polyps in real-life clinical practice.
All consecutive adult patients undergoing colonoscopy with at least one detected polyp will be included. Optical prediction of polyp histology will be recorded during the procedure. All polyps will be resected and sent for histopathological analysis according to standard practice. No modification of patient management will occur as part of the study.
The primary objective is to assess the concordance between optical prediction and histopathology before and after implementation of the digital training program. Secondary objectives include evaluation of prediction performance according to polyp characteristics and assessment of potential implications for clinical practice.
Detailed description
Colorectal cancer (CRC) prevention depends on the detection and removal of precursor lesions during colonoscopy. Optical diagnosis of colorectal polyps using enhanced imaging technologies has been proposed to improve procedural efficiency and to potentially support management strategies such as resect-and-discard for diminutive lesions. However, variability in optical characterization accuracy remains a major limitation in routine practice.
COLO-PREDICT is a prospective, single-center, observational study conducted in real-life clinical practice. The study aims to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histologic prediction of colorectal polyps.
Adult patients undergoing colonoscopy with at least one detected polyp will be consecutively included. During each procedure, the endoscopist will record an optical prediction of polyp histology based on standard classification systems and routine imaging modalities. All polyps will be resected and submitted for histopathological examination in accordance with current standard of care. No modification of patient management, surveillance interval, or therapeutic strategy will be implemented as part of the study.
The digital training program consists of a structured educational intervention focused on optical characterization principles, image-based training, and performance assessment in a simulated environment. The study evaluates optical prediction performance before and after implementation of this training program in routine practice.
The primary endpoint is the rate of concordance between optical histologic prediction and final histopathology. Secondary endpoints include diagnostic performance parameters (sensitivity, specificity, positive predictive value, negative predictive value), performance according to polyp size and location, and assessment of potential implications for clinical practice efficiency.
Data will be collected prospectively and analyzed using appropriate statistical methods to compare performance before and after training. The study is conducted in accordance with ethical and regulatory requirements and does not introduce additional risk for patients, as all clinical decisions follow standard practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Colonoscopy Cohort | – | Other: Digital Training Program (Colo-ID)Adult patients undergoing colonoscopy with at least one detected colorectal polyp. Optical histology prediction is recorded during routine clinical practice. All polyps are resected and sent for histopathological analysis according to standard care. No modification of patient management is performed as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing colonoscopy in routine clinical practice at Clinique Paris-Bercy, in whom at least one colorectal polyp is detected and optically characterized by participating endoscopists. The study evaluates optical histology prediction performance before and after implementation of the Colo-ID digital training program. Histopathological analysis of resected polyps serves as the reference standard when applicable.
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Patients undergoing colonoscopy in routine clinical practice at the participating center
- At least one colorectal polyp detected during colonoscopy
- Optical histology prediction recorded during the procedure
- Histopathological analysis available for resected polyps (reference standard)
Key exclusion criteria (3 listed)
- Patients aged <18 years
- Refusal/opposition to use of data (if applicable under local regulations)
- Missing key study data (e.g., no recorded optical prediction or no histopathology result)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Training Program (Colo-ID)Structured educational program for endoscopists focused on optical polyp characterization. No direct intervention on patients. | Other | Prospective Colonoscopy Cohort |
Primary outcome
Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program
Time frame: Pre-training period and post-training period between February 2026 and June 2026.
Difference in overall accuracy of optical histologic prediction of colorectal polyps (agreement with final histopathology) between the pre-training period and the post-training period following implementation of the Colo-ID training program in routine clinical practice.
6 secondary outcomes
Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies
Time frame: From February 2026 to June 2026.
Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard
Time frame: From February 2026 to June 2026.
Inter-Operator Variability in Optical Prediction Accuracy
Time frame: Pre- and post-training periods between February 2026 and June 2026.
Individual and Collective Performance Evolution After Training
Time frame: Pre- and post-training periods between February 2026 and June 2026.
Estimated Potential Cost and Environmental Savings Associated With Resect-and-Discard and Diagnose-and-Leave Strategies Eligibility
Time frame: End of study analysis (June 2026).
Change in Questionnaire Score Assessing Confidence, Knowledge, and Readiness to Implement Resect-and-Discard and Diagnose-and-Leave Strategies
Time frame: Pre-training and post-training (within February 2026 to June 2026).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 21353837Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.
- Background: PubMed 32572858Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
- Background: PubMed 34872120Houwen BBSL, Hassan C, Coupe VMH, Greuter MJE, Hazewinkel Y, Vleugels JLA, Antonelli G, Bustamante-Balen M, Coron E, Cortas GA, Dinis-Ribeiro M, Dobru DE, East JE, Iacucci M, Jover R, Kuvaev R, Neumann H, Pellise M, Puig I, Rutter MD, Saunders B, Tate DJ, Mori Y, Longcroft-Wheaton G, Bisschops R, Dekker E. Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2022 Jan;54(1):88-99. doi: 10.1055/a-1689-5130. Epub 2021 Dec 6.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available upon reasonable request to the corresponding investigator, subject to institutional approval and data use agreement.
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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.
Coralie Declerck, Ms. contact
David D Karsenti principal investigator
Centre d'Explorations Digestives
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 Colorectal Polyps, run by Clinique Paris-Bercy at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Karsenti, MD (+33145486565, karsenti.paris@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program (time frame: Pre-training period and post-training period between February 2026 and June 2026.). 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 NCT07424391, which also lists 3 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 23 Feb 2026.