Esophagus Cancer Clinical Trial
Official title:
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
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.
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 ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Completed |
NCT00201747 -
Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
|
Phase 2 | |
Recruiting |
NCT06036563 -
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
|
||
Not yet recruiting |
NCT05023928 -
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
|
Phase 1 | |
Recruiting |
NCT03941626 -
Autologous CAR-T/TCR-T Cell Immunotherapy for Solid Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT04907643 -
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
|
N/A | |
Recruiting |
NCT02988921 -
MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy
|
N/A | |
Completed |
NCT02979691 -
Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01
|
Phase 2/Phase 3 | |
Terminated |
NCT02797405 -
Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
|
N/A | |
Recruiting |
NCT03347630 -
Pre-operative MRI of Esophagus Cancer
|
N/A | |
Completed |
NCT00193141 -
Chemotherapy With or Without Surgical Resection in Locally Advanced Esophageal Cancer
|
Phase 2 | |
Recruiting |
NCT05626309 -
Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
|
N/A | |
Completed |
NCT05615129 -
Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting
|
||
Recruiting |
NCT04821765 -
Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer
|
Phase 2 | |
Terminated |
NCT03108885 -
Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
|
||
Recruiting |
NCT04046575 -
Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer
|
Phase 1 | |
Recruiting |
NCT06126406 -
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) for CEA Positive Advanced Malignant Solid Tumors
|
Phase 1 | |
Completed |
NCT02552121 -
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02001623 -
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT06160557 -
A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma
|