Colorectal NeoplasmsESCONCT03486418
European Serrated Adenoma Classification Score
An observational study of Colorectal Neoplasms, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to Apr 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine colonoscopy
Who may be able to join
- indication for colonoscopy
- patients >= 18 years
Who cannot join
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.
In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).
- Conditions
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical diagnosis of each colorectal polyp
The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after;
Measured: Participants will be followed for the duration of the study an expected average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Apr 2018
- Primary completion1 Sep 2020
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486418
- Sponsor's protocol ID
- ESCO
- Acronym
- ESCO
- Status last verified
- Sep 2020
- First submitted
- 27 Mar 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
- ClinicalTrials.gov ID
- NCT03486418
- Acronym / sponsor ID
- ESCO / ESCO
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 3 Apr 2018 (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.
The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.
In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine colonoscopy
Key inclusion criteria (2 listed)
- indication for colonoscopy
- patients >= 18 years
Key exclusion criteria (5 listed)
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
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
Optical diagnosis of each colorectal polyp
Time frame: Participants will be followed for the duration of the study an expected average of 6 month
The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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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. 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 Colorectal Neoplasms, run by Technical University of Munich at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. 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 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?
Results are not available in the source record.
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?
Optical diagnosis of each colorectal polyp (time frame: Participants will be followed for the duration of the study an expected average of 6 month). 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 18 Sep 2020.