Skin CancerGALAXYNCT03079232
First Optical Coherence Microscopy in Dermato-oncology
A study testing OCTAV Patient in people with Skin Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- OCTAV Patient
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2017to 1 Aug 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
- Consent form signed
- Major patient
- Aged between 18 to 40 years
- Consent form signed
- Patient of the dermatology department with non-pathological forearm skin
Who cannot join
- Allergy or intolerance to immersion oil (used for microscopy)
- If female, pregnant or breast-feeding
- Patient unable to stand still for 60 seconds
- Skin lesions located near patient eyes (<3 cm)
- FOR CONTROL GROUP
- Allergy or intolerance to immersion oil (used for microscopy)
- If female, pregnant or breast-feeding
- Patient unable to stand still for 60 seconds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).
Read the detailed description
At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.
This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.
- Conditions
- Skin Cancer
- Being tested
- OCTAV Patient, OCTAV Control group
- Keywords
- Optical biopsy, Skin cancer, Diagnostic performance
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTAV PatientDevice
Also called OCTAV, DAMAE Medical, Paris, France
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
OCTAV Control groupDevice
Also called OCTAV, DAMAE Medical, Paris, France
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
| Study group | Role | What they receive |
|---|---|---|
| OCTAV Patient | Experimental | The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) Receives: Device: OCTAV Patient |
| OCTAV Control group | Experimental | Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) Receives: Device: OCTAV Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Measured: Day 1
Specificity
Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Measured: Day 1
Secondary outcomes (1)
Measure of the thickness of the different skin layers (mm)
Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start28 Mar 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group of patients One group of non skin cancer patients
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- DAMAE Médical
- Responsible party
- Sponsor
- Investigators
- Jean-Luc PERROT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneCécile DUPONT, PhD, Study chair, Damae Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079232
- Sponsor's protocol ID
- 1608015
- Other IDs
- 2016-A00319-42
- Acronym
- GALAXY
- Status last verified
- Feb 2025
- First submitted
- 16 Mar 2016
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
- ClinicalTrials.gov ID
- NCT03079232
- Acronym / sponsor ID
- GALAXY / 1608015
- Conditions
- Skin Cancer
- Keywords
- Optical biopsy, Skin cancer, Diagnostic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- DAMAE Médical
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 14 Mar 2017 (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.
OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).
Detailed description
At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.
This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group of patients One group of non skin cancer patients
| Arm | Type | Receives |
|---|---|---|
| OCTAV Patient | Experimental | Device: OCTAV PatientThe patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) |
| OCTAV Control group | Experimental | Device: OCTAV Control groupControl group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
- Consent form signed
- Major patient
- Aged between 18 to 40 years
- Consent form signed
Key exclusion criteria (8 listed)
- Allergy or intolerance to immersion oil (used for microscopy)
- If female, pregnant or breast-feeding
- Patient unable to stand still for 60 seconds
- Skin lesions located near patient eyes (<3 cm)
- FOR CONTROL GROUP
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 |
|---|---|---|
| OCTAV PatientAlso: OCTAV, DAMAE Medical, Paris, FranceIn vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient. | Device | OCTAV Patient |
| OCTAV Control groupAlso: OCTAV, DAMAE Medical, Paris, FranceIn vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient. | Device | OCTAV Control group |
Primary outcome
Sensitivity
Time frame: Day 1
Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Specificity
Time frame: Day 1
Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
1 secondary outcome
Measure of the thickness of the different skin layers (mm)
Time frame: Day 1
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 10 Feb 2025.
- 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.
Jean-Luc PERROT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Cécile DUPONT, PhD study chair
Damae Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCTAV Patient in people with Skin Cancer, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 inclusion and 8 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 10 Feb 2025. 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?
Sensitivity (time frame: Day 1). The study lists 2 primary outcomes in all. 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 10 Feb 2025.