Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia (PatheBarett)
December 13, 2018 updated by: Institut Paoli-Calmettes
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Study Type
Observational
Enrollment (Actual)
18
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
-
-
Bouches-du Rhône
-
Marseille, Bouches-du Rhône, France, 13009
- Institut Paoli-Calmettes
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Description
Inclusion Criteria:
- patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Exclusion Criteria:
-
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
DHG on Barrett's esophagus
patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection
|
Pathological revision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influence of histological concordance on the risk of recurrence
Time Frame: 1 day
|
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of histological factors of recurrence.
Time Frame: 1 day
|
Identification of histological factors of recurrence.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
September 24, 2018
First Submitted That Met QC Criteria
September 25, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
December 14, 2018
Last Update Submitted That Met QC Criteria
December 13, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PatheBarett-IPC 2016-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.