- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048447
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications
August 5, 2019 updated by: Jean Christophe Saurin, Hôpital Edouard Herriot
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts.
Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy.
Different classifications have been proposed to predict histology depending on the endoscopic aspect.
Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one.
Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification.
However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria.
We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose.
We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files.
Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published.
To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
206
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhône Alpes
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Lyon, Rhône Alpes, France, 69437
- Edouard Herriot Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Colic Neoplasia Patients
Description
Inclusion Criteria:
- The participants were gastroenterologist doctors (experts, general or internal).
- Lesions presented were resected endoscopically after completion of a picture file.
- Pathology available for presented lesions.
- Participants signed informed consent and voluntarily participated in the characterization of these 206 lesions.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of the interobserver Concordance of the CONECCT classification compared to the 6 other existing ones
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2018
Primary Completion (ACTUAL)
August 1, 2018
Study Completion (ACTUAL)
August 1, 2019
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
August 5, 2019
First Posted (ACTUAL)
August 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFED PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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