- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046144
Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors (Micro3)
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 RCM, we currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint Etienne, France, 42000
- CHU de Saint Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Bad quality images
- Insufficient number of images
- Uncertain diagnosis given by the pathologist
- Refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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. 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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To analyse the picture to assess the relevance of each technique for the diagnostic of malignant and benign pigmented lesions.
Time Frame: Day 1
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The nature of the tumor is diagnosed by an imaging technique if we can find on the images the main characteristics belonging to a certain tumor. After this we can calculate the sensitivity, specificity of each technique. |
Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of different imaging techniques
Time Frame: Day 1
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To compare the performance of combination of 2 techniques to assess if the performance is better than 1 technique alone.
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Day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Luc PERROT, MD PhD, CHU SAINT-ETIENNE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Hyperpigmentation
- Pigmentation Disorders
- Neoplasms, Basal Cell
- Melanosis
- Melanoma
- Keratosis
- Lentigo
- Hutchinson's Melanotic Freckle
- Carcinoma, Basal Cell
- Keratosis, Seborrheic
Other Study ID Numbers
- IRBN1142023/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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