Esophagus CancerOESOCiTyNCT03467529
Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
An observational study of Esophagus Cancer, run by Nantes University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Non interventional study
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2018to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients will be recruited by the Clinical investigation center by reviewing the scheduled SCC resections each week. All patients scheduled for an endoscopic resection of SCC will be considered for inclusion in the study. The study itself will take place in the department of gastroenterology. Recruitment within one year of inclusion will be possible because our unit is a regional reference center for interventional endoscopy.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Any contraindication for endoscopic treatment
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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.
Read the 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
- Conditions
- Esophagus Cancer
- Being tested
- Non interventional study
- Keywords
- Superficial esophageal cancer, Squamous cell cancer, Mini invasive imaging, Pre therapeutic assessment, Optical coherence tomography
- Medical subject headings
- Esophageal Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Non interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after endoscopic resection (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start6 Nov 2018
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Coron, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467529
- Sponsor's protocol ID
- RC16_0456
- Acronym
- OESOCiTy
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2017
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study
- ClinicalTrials.gov ID
- NCT03467529
- Acronym / sponsor ID
- OESOCiTy / RC16_0456
- Conditions
- Esophagus Cancer
- Keywords
- Superficial esophageal cancer, Squamous cell cancer, Mini invasive imaging, Pre therapeutic assessment, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients will be recruited by the Clinical investigation center by reviewing the scheduled SCC resections each week. All patients scheduled for an endoscopic resection of SCC will be considered for inclusion in the study. The study itself will take place in the department of gastroenterology. Recruitment within one year of inclusion will be possible because our unit is a regional reference center for interventional endoscopy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Any contraindication for endoscopic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyNon interventional study | Other | – |
Primary outcome
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: * 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Coron, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.