Colorectal CancerNCT06920680
ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
An observational study of Colorectal Cancer and Colonoscopy, run by Wuerzburg University Hospital at 2 sites in Germany.
Trial summary
With the participants help, the investigators aim to track treatment methods, treatment outcomes, and adverse events, as well as document the treatment strategies used during endoscopic colorectal cancer prevention and treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colonoscopy, Polypectomy
- How many people
- 1,834 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2024to Oct 2027
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with planned diagnostic or therapeutic colonoscopy.
Who may be able to join
- Indication for diagnostic or therapeutic colonoscopy
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376
Martin Schich, Dr. med, +49 711 8101-0, martin.schich@rbk.de
Martin Schich, Dr. med
- Recruiting
University Hospital Würzburg
Würzburg, Bavaria, 97080
Thomas J. Lux, Dr. med. M. Sc., +49931-201-40247, lux_t1@ukw.de
Yvonne Josef, +49931-201-40255, josef_y@ukw.de
About this study
With the participants help, the investigators aim to track treatment methods, treatment outcomes, and adverse events, as well as document the treatment strategies used during endoscopic colorectal cancer prevention and treatment. This will allow us to verify if the results from targeted clinical studies and current scientific knowledge are also reflected in the real world. Additionally, the investigators want to use the collected videos and findings to support the training of doctors. During each examination, doctors must be able to accurately assess the inside of the body. Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases. The investigators aim to provide doctors with the opportunity to learn outside of real patient examinations and benefit from the experiences of others.
Furthermore, the investigators want to make the findings and video data accessible to the scientific community. Since scientific studies rarely publish raw data for this purpose, there is currently no large and constantly updated database of findings, images, and videos. If a study requires such data, new data must be collected with great organizational and financial effort. As a result, different studies are only partially comparable, and their significance is reduced.
Read more
By publishing the data, a valuable information source for medical professionals in training, continuing education, and advanced training is created. Researchers also benefit from this data: New technologies, such as image analysis software, can be tested and compared on a consistent basis. Therefore, participation in this study makes a valuable contribution to the foundation of good medical care: education, research, and quality assurance.
Primary Study Goal:
The study aims to evaluate the effectiveness and safety of different endoscopic resection techniques. Effectiveness is defined as achieving a complete removal of the lesion (R0 resection) or having a clear follow-up in more than 90% of cases. Safety is defined as having less than 3% of cases result in complications like perforation, uncontrollable bleeding, or the need for unplanned follow-up due to issues like interval bleeding or perforation. The target diagnostic accuracy is 95%.
Secondary Study Goals:
- Ensure that in 90% of cases, the recommended follow-up interval aligns with current national guidelines based on the number, size, and histopathology of polyps.
- Achieve successful retrieval of polyps in more than 95% of cases.
- Document minor bleedings, defined as continuous bleeding for over 30 seconds that requires clipping.
Tertiary Study Goal:
Develop software that can identify and mask sensitive information (such as names, birth dates, examination dates, and video sections outside the human body) in videos from 1,000 examinations, or flag them for manual review. Similarly, the software should identify and remove sensitive text information in the reports, such as names, birth dates, case numbers, examiners, and phone numbers, or mark the text for manual review.
- Conditions
- Colorectal Cancer, Colonoscopy, Polypectomy
- Keywords
- colorectal cancer, colonoscopy, standardized documentation, interventional endoscopy
- Medical subject headings
- Colorectal 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 |
|---|---|---|
| Colonoscopy | All patients recruited in a study center are included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection Rate by Removal Method (lesion size >= 20 mm)
Rate of histologically complete resection for removed pre-cancerous and cancerous lesions >= 20 mm.
Measured: through study completion, an average of 1 year
Inconspicious follow-up by method of Removal (lesion >= 20 mm)
Rate of macroscopically endoscopic follow-up examinations within 1 year if performed
Measured: through study completion, an average of 1 year
Major Complication Rate (lesion size >= 20 mm)
Rate of examination related major complications defined as endoscopically uncontrollable bleedings or perforations.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Intervention time by method of removal (>= 20 mm)
Time required from discovery of a polyp to completed treatment including handling of immediate complications.
Measured: through study completion, an average of 1 year
Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)
Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 1,834 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Medical Center, Krankenhaus Barmherzige Brüder, Regensburg, Universitätsklinikum Hamburg-Eppendorf, Klinikum Ludwigsburg
- Responsible party
- Sponsor
- Investigators
- Alexander Meining, Prof., Study chair, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920680
- Sponsor's protocol ID
- 151/23-sc
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized images from endoscopy examination videos may be published on an research / educational platform.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
- ClinicalTrials.gov ID
- NCT06920680
- Acronym / sponsor ID
- 151/23-sc
- Conditions
- Colorectal Cancer, Colonoscopy, Polypectomy
- Keywords
- colorectal cancer, colonoscopy, standardized documentation, interventional endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,834 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Robert Bosch Medical Center, Krankenhaus Barmherzige Brüder, Regensburg, Universitätsklinikum Hamburg-Eppendorf, Klinikum Ludwigsburg
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
With the participants help, the investigators aim to track treatment methods, treatment outcomes, and adverse events, as well as document the treatment strategies used during endoscopic colorectal cancer prevention and treatment. This will allow us to verify if the results from targeted clinical studies and current scientific knowledge are also reflected in the real world. Additionally, the investigators want to use the collected videos and findings to support the training of doctors. During each examination, doctors must be able to accurately assess the inside of the body. Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases. The investigators aim to provide doctors with the opportunity to learn outside of real patient examinations and benefit from the experiences of others.
Furthermore, the investigators want to make the findings and video data accessible to the scientific community. Since scientific studies rarely publish raw data for this purpose, there is currently no large and constantly updated database of findings, images, and videos. If a study requires such data, new data must be collected with great organizational and financial effort. As a result, different studies are only partially comparable, and their significance is reduced.
By publishing the data, a valuable information source for medical professionals in training, continuing education, and advanced training is created. Researchers also benefit from this data: New technologies, such as image analysis software, can be tested and compared on a consistent basis. Therefore, participation in this study makes a valuable contribution to the foundation of good medical care: education, research, and quality assurance.
Primary Study Goal:
The study aims to evaluate the effectiveness and safety of different endoscopic resection techniques. Effectiveness is defined as achieving a complete removal of the lesion (R0 resection) or having a clear follow-up in more than 90% of cases. Safety is defined as having less than 3% of cases result in complications like perforation, uncontrollable bleeding, or the need for unplanned follow-up due to issues like interval bleeding or perforation. The target diagnostic accuracy is 95%.
Secondary Study Goals:
- Ensure that in 90% of cases, the recommended follow-up interval aligns with current national guidelines based on the number, size, and histopathology of polyps.
- Achieve successful retrieval of polyps in more than 95% of cases.
- Document minor bleedings, defined as continuous bleeding for over 30 seconds that requires clipping.
Tertiary Study Goal:
Develop software that can identify and mask sensitive information (such as names, birth dates, examination dates, and video sections outside the human body) in videos from 1,000 examinations, or flag them for manual review. Similarly, the software should identify and remove sensitive text information in the reports, such as names, birth dates, case numbers, examiners, and phone numbers, or mark the text for manual review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | – | –All patients recruited in a study center are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with planned diagnostic or therapeutic colonoscopy.
Key inclusion criteria (1 listed)
- Indication for diagnostic or therapeutic colonoscopy
Key exclusion criteria (1 listed)
- -
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
R0 Resection Rate by Removal Method (lesion size >= 20 mm)
Time frame: through study completion, an average of 1 year
Rate of histologically complete resection for removed pre-cancerous and cancerous lesions >= 20 mm.
Inconspicious follow-up by method of Removal (lesion >= 20 mm)
Time frame: through study completion, an average of 1 year
Rate of macroscopically endoscopic follow-up examinations within 1 year if performed
Major Complication Rate (lesion size >= 20 mm)
Time frame: through study completion, an average of 1 year
Rate of examination related major complications defined as endoscopically uncontrollable bleedings or perforations.
2 secondary outcomes
Intervention time by method of removal (>= 20 mm)
Time frame: through study completion, an average of 1 year
Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)
Time frame: through study completion, an average of 1 year
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 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized images from endoscopy examination videos may be published on an research / educational platform.
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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.
Alexander Meining, Prof. study chair
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colonoscopy, run by Wuerzburg University Hospital at 2 sites in Germany.
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 1 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Thomas J. Lux, Dr. med. M. Sc. (+49 931 201 40247, lux_t1@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate by Removal Method (lesion size >= 20 mm) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 22 Dec 2025.