Esophagus Cancer Clinical Trial
— OESOCiTyOfficial title:
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
NCT number | NCT03467529 |
Other study ID # | RC16_0456 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 6, 2018 |
Est. completion date | July 1, 2022 |
Verified date | February 2024 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance between FFOCT findings and pathology based on the Paris classification of superficial esophageal cancer in pathology | The principal objective of this study will be reached if:
the tumoral lesion is correctly identified in the specimen in FFOCT images and/or the normal esophageal mucosa and submucosal and/or normal vessels are correctly identified in the specimen in FFOCT images in at least 8 specimens. |
Immediately after endoscopic resection (Day 0) |
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