NCT06046144

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

June 24, 2024

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

September 14, 2023

Last Update Submit

June 20, 2024

Conditions

Basal Cell CarcinomaLentigo MalignaMelanomaNevusSeborrheic KeratosisLentigo

Keywords

Melanoma diagnosisDiagnosis ImagingFluorescence-Advanced videodermatoscopyReflectance confocal microscopySuper-high magnification dermoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (1)

  • Comparison of performance of imaging techniques

    Day 1

Study Arms (1)

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.

Diagnostic Test: Fluorescence-Advanced videodermatoscopyDiagnostic Test: Reflectance confocal microscopyDiagnostic Test: Super-high magnification dermoscopy

Interventions

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.

Patients with a pigmented skin lesion
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.

Patients with a pigmented skin lesion
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.

Patients with a pigmented skin lesion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Bad quality images
  • Insufficient number of images
  • Uncertain diagnosis given by the pathologist
  • Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Carcinoma, Basal CellHutchinson's Melanotic FreckleMelanomaNevusKeratosis, SeborrheicLentigo

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesKeratosisMelanosisHyperpigmentationPigmentation Disorders

Study Officials

  • Jean-Luc PERROT, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

November 2, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

June 24, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)