- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03467529
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study (OESOCiTy)
New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.
Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.
Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.
To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
General study methodology
The study presents the following characteristics:
- Observational
- Non interventional imaging study
- Single-centre
- Not controlled
- Prospective Tests and analysis CRF
- Filled by the investigator
- Data from the medical file of the patient Imaging
- As standard of care
- Before endoscopic resection the lesion will be characterized and pictures will be made using white light endoscopy, magnification techniques and electronic chromoendoscopy
- Immediately after endoscopic resection, the specimen will be prepared, oriented and scanned using the FFOCT device (CE marking)
- Imaging movies will be then reviewed by trained readers and compared to movies of healthy patients, findings will be described
- Imaging movies will be compared to pathology slides
Pathology
- After scanning the specimen will be sent to pathology for analysis
- The pathology slides will be scanned to be kept in the study record together with their interpretation
Study schedule
- Total length of study: 24 months
- Methodology and regulatory: 6 months
- Recruitment period: 1 year
- Recruitment among the patients scheduled for the endoscopic procedure in the operative room
- One single visit = inclusion the day of the procedure
- No follow-up required
- Analyses: 3 months
- Paper writing: 3 months
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Emmanuel Coron, Pr
- Phone Number: +33 (0)2-40-08-30-97
- Email: emmanuel.coron@chu-nantes.fr
Study Contact Backup
- Name: Lucille Quénéhervé, Dr
- Phone Number: +33 (0)2-40-08-31-52
- Email: lucille.queneherve@chu-brest.fr
Study Locations
-
-
-
Nantes, France, 44000
- Nantes University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of 18 years and more
- Confirmed diagnosis of SCC based on previous biopsy
- Indication for endoscopic resection
- Patient who has read the information notice and confirmed its willing to participate
Exclusion Criteria:
- Pregnancy
- Any contraindication for endoscopic treatment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology
Time Frame: Immediately after endoscopic resection (Day 0)
|
The principal objective of this study will be reached if:
|
Immediately after endoscopic resection (Day 0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emmanuel Coron, Pr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
Other Study ID Numbers
- RC16_0456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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