Cutaneous TumorDERMOCTAVNCT05340543
Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)
An observational study of Cutaneous Tumor and Optical Coherence Tomography, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Tumor, Optical Coherence Tomography, Basal Cell Carcinoma
- What is being tested?
- Confocal optical coherence tomography - OCTAVE
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2021to 16 Jun 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: Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
Who may be able to join
- Patient, male or female, at least 18 years old
- Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
- Affiliated patient or beneficiary of a social security scheme
- Patient having signed the free and informed consent
Who cannot join
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé d'Antony Antony
Antony, IDF, 92160
Pierre-André BECHEREL, Dr, +33668645429, pierre-andre.becherel@ramsaysante.fr
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
Read the detailed description
There are mainly 3 types of skin cancer: melanoma, basal cell carcinoma and squamous cell carcinoma. The diagnosis of skin cancers is now based on anatomo-pathological evidence. However, given the progress made, imaging is a technique that now has a full role in the diagnosis of these pathologies. This is particularly the case of confocal optical coherence tomography (LC-OCT), which is a recent imaging technique that has proven itself in ophthalmology with the obtaining of precise images of the retina.
LC-OCT can be applied in dermatology according to the following principle: the low intensity laser beam delivered by the LC-OCT device interferes with the melanin, is reflected and makes it possible to instantly acquire a 3D cross-sectional image of the skin, with a resolution of the order of a micrometer. It is finally an "optical echography", the light allowing a tissue definition much higher than the ultrasonic waves. It is therefore possible to obtain sections of histological resolution, and to scan the entire area studied.
Based on this principle, DAMAE has created OCTAV®, a class 1 medical device intended to allow "an in-depth study of skin pathologies", which is currently being evaluated in vivo as part of a clinical trial ( OCTAV - NCT03731247).
The device evaluated in the OCTAV trial does not include the "dermoscope" function. However, coupled with an image capture and processing system, it would increase the magnification obtained from 10 times to 20 or 30 times, allowing precise targeting of the lesion. As a result, a new prototype of OCTAV® has been developed which integrates the "dermoscope" function.
In this context, this project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
- Conditions
- Cutaneous Tumor, Optical Coherence Tomography, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Being tested
- Confocal optical coherence tomography - OCTAVE
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal optical coherence tomography - OCTAVEProcedure or surgery
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
| Study group | Role | What they receive |
|---|---|---|
| Patient with basal cell carcinoma | - CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels. Receives: Procedure: Confocal optical coherence tomography - OCTAVE | |
| Patient with squamous cell carcinoma | - CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels Receives: Procedure: Confocal optical coherence tomography - OCTAVE | |
| Patient with melanoma | Melanoma: Destructured dermal-epidermal junction (DEJ), presence of pagetoid cells, clusters of atypical melanocytes, dendritic cells Receives: Procedure: Confocal optical coherence tomography - OCTAVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance RATE
Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start16 Dec 2021
- Primary completion16 Jun 2022 (estimated)
- Study completion16 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous TumorStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
- Investigators
- DRE RAMSAYGDS, Study chair, GCS Ramsay Santé pour l'Enseignement et la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340543
- Sponsor's protocol ID
- 2019-A02609-48
- Acronym
- DERMOCTAV
- Status last verified
- Jan 2022
- First submitted
- 15 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)
- ClinicalTrials.gov ID
- NCT05340543
- Acronym / sponsor ID
- DERMOCTAV / 2019-A02609-48
- Conditions
- Cutaneous Tumor, Optical Coherence Tomography, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 16 Jun 2022 (estimated)
- Study completion
- 16 Jun 2022 (estimated)
- First posted
- 22 Apr 2022 (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.
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
Detailed description
There are mainly 3 types of skin cancer: melanoma, basal cell carcinoma and squamous cell carcinoma. The diagnosis of skin cancers is now based on anatomo-pathological evidence. However, given the progress made, imaging is a technique that now has a full role in the diagnosis of these pathologies. This is particularly the case of confocal optical coherence tomography (LC-OCT), which is a recent imaging technique that has proven itself in ophthalmology with the obtaining of precise images of the retina.
LC-OCT can be applied in dermatology according to the following principle: the low intensity laser beam delivered by the LC-OCT device interferes with the melanin, is reflected and makes it possible to instantly acquire a 3D cross-sectional image of the skin, with a resolution of the order of a micrometer. It is finally an "optical echography", the light allowing a tissue definition much higher than the ultrasonic waves. It is therefore possible to obtain sections of histological resolution, and to scan the entire area studied.
Based on this principle, DAMAE has created OCTAV®, a class 1 medical device intended to allow "an in-depth study of skin pathologies", which is currently being evaluated in vivo as part of a clinical trial ( OCTAV - NCT03731247).
The device evaluated in the OCTAV trial does not include the "dermoscope" function. However, coupled with an image capture and processing system, it would increase the magnification obtained from 10 times to 20 or 30 times, allowing precise targeting of the lesion. As a result, a new prototype of OCTAV® has been developed which integrates the "dermoscope" function.
In this context, this project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with basal cell carcinoma | – | Procedure: Confocal optical coherence tomography - OCTAVE- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels. |
| Patient with squamous cell carcinoma | – | Procedure: Confocal optical coherence tomography - OCTAVE- CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels |
| Patient with melanoma | – | Procedure: Confocal optical coherence tomography - OCTAVEMelanoma: Destructured dermal-epidermal junction (DEJ), presence of pagetoid cells, clusters of atypical melanocytes, dendritic cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
Key inclusion criteria (4 listed)
- Patient, male or female, at least 18 years old
- Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
- Affiliated patient or beneficiary of a social security scheme
- Patient having signed the free and informed consent
Key exclusion criteria (3 listed)
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
- Patient hospitalized without consent
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 |
|---|---|---|
| Confocal optical coherence tomography - OCTAVEAn ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function | Procedure or surgery | Patient with basal cell carcinoma, Patient with melanoma, Patient with squamous cell carcinoma |
Primary outcome
Concordance RATE
Time frame: 10 days
Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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.
Marie-Hélène Barba contact
DRE RAMSAYGDS study chair
GCS Ramsay Santé pour l'Enseignement et la Recherche
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 Cutaneous Tumor and Optical Coherence Tomography, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean francois OUDET (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance RATE (time frame: 10 days). 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 22 Apr 2022.