Basal Cell CarcinomaMicro3NCT06046144
Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors
An observational study of Basal Cell Carcinoma and Lentigo Maligna, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma, Lentigo Maligna, Melanoma
- What is being tested?
- Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy and Super-high magnification dermoscopy
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2022to 1 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.
Who may be able to join
- Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.
Who cannot join
- Bad quality images
- Insufficient number of images
- Uncertain diagnosis given by the pathologist
- Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors. Monocentric Retrospective Study of 170 Tumors
Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature.
In addition to Reflectance confocal microscopy (RCM), it currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).
Read the detailed description
Several studies have demonstrated their interest in the in vivo diagnosis of melanocytic tumors, but without any comparison between these methods.
In our current practice, many patients have benefited from these 3 imaging modalities for benign and malignant lesions.
Therefore, our aim is to analyze these images and compare their performance in the diagnosis of benign and malignant pigmented lesions.
- Conditions
- Basal Cell Carcinoma, Lentigo Maligna, Melanoma, Nevus, Seborrheic Keratosis, Lentigo
- Being tested
- Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy, Super-high magnification dermoscopy
- Keywords
- Melanoma diagnosis, Diagnosis Imaging, Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy, Super-high magnification dermoscopy
- Medical subject headings
- Carcinoma, Basal Cell, Hutchinson's Melanotic Freckle, Melanoma, Nevus, Keratosis, Seborrheic, Lentigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence-Advanced videodermatoscopyDiagnostic test
Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern.
Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.
Reflectance confocal microscopyDiagnostic test
Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern.
Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.
Super-high magnification dermoscopyDiagnostic test
Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern.
Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a pigmented skin lesion | Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring. Receives: Diagnostic Test: Fluorescence-Advanced videodermatoscopy; Diagnostic Test: Reflectance confocal microscopy; Diagnostic Test: Super-high magnification dermoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the the relevance of each technique for the diagnostic of pigmented lesions.
The nature of the tumor is diagnosed by the imaging technique.
Measured: Day 1
Secondary outcomes (1)
Comparison of performance of imaging techniques
Analyze the results of imaging of each technique.
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 posted21 Sep 2023
- Study start2 Nov 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc PERROT, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046144
- Sponsor's protocol ID
- IRBN1142023/CHUSTE
- Acronym
- Micro3
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2023
- Last updated
- 24 Jun 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors. Monocentric Retrospective Study of 170 Tumors
- ClinicalTrials.gov ID
- NCT06046144
- Acronym / sponsor ID
- Micro3 / IRBN1142023/CHUSTE
- Conditions
- Basal Cell Carcinoma, Lentigo Maligna, Melanoma, Nevus, Seborrheic Keratosis, Lentigo
- Keywords
- Melanoma diagnosis, Diagnosis Imaging, Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy, Super-high magnification dermoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature.
In addition to Reflectance confocal microscopy (RCM), it currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).
Detailed description
Several studies have demonstrated their interest in the in vivo diagnosis of melanocytic tumors, but without any comparison between these methods.
In our current practice, many patients have benefited from these 3 imaging modalities for benign and malignant lesions.
Therefore, our aim is to analyze these images and compare their performance in the diagnosis of benign and malignant pigmented lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a pigmented skin lesion | – | Diagnostic Test: Fluorescence-Advanced videodermatoscopy, Diagnostic Test: Reflectance confocal microscopy, Diagnostic Test: Super-high magnification dermoscopyPatients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.
Key inclusion criteria (1 listed)
- Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring.
Key exclusion criteria (4 listed)
- Bad quality images
- Insufficient number of images
- Uncertain diagnosis given by the pathologist
- Refusal
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 |
|---|---|---|
| Fluorescence-Advanced videodermatoscopyDatas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface. | Diagnostic test | Patients with a pigmented skin lesion |
| Reflectance confocal microscopyDatas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface. | Diagnostic test | Patients with a pigmented skin lesion |
| Super-high magnification dermoscopyDatas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface. | Diagnostic test | Patients with a pigmented skin lesion |
Primary outcome
To compare the the relevance of each technique for the diagnostic of pigmented lesions.
Time frame: Day 1
The nature of the tumor is diagnosed by the imaging technique.
1 secondary outcome
Comparison of performance of imaging techniques
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 24 Jun 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.
Jean-Luc PERROT, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Basal Cell Carcinoma and Lentigo Maligna, 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 1 inclusion and 4 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 24 Jun 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?
To compare the the relevance of each technique for the diagnostic of pigmented lesions. (time frame: Day 1). 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 24 Jun 2024.