Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors

NCT ID: NCT06046144

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-02

Study Completion Date

2023-05-01

Brief Summary

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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

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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

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Basal Cell Carcinoma Lentigo Maligna Melanoma Nevus Seborrheic Keratosis Lentigo

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Fluorescence-Advanced videodermatoscopy

Intervention Type DIAGNOSTIC_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 microscopy

Intervention Type DIAGNOSTIC_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 dermoscopy

Intervention Type DIAGNOSTIC_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.

Interventions

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Fluorescence-Advanced videodermatoscopy

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.

Intervention Type DIAGNOSTIC_TEST

Reflectance confocal microscopy

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.

Intervention Type DIAGNOSTIC_TEST

Super-high magnification dermoscopy

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc PERROT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu de Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN1142023/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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