Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)
DERMOCTAV
1 other identifier
observational
150
1 country
1
Brief Summary
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2021
CompletedFirst Submitted
Initial submission to the registry
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedApril 22, 2022
January 1, 2022
6 months
April 15, 2022
April 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Concordance RATE
Correlation between LC-OCT images on the first 500 microns of the skin and histological images of skin and tumor excision analysis.
10 days
Study Arms (3)
Patient with basal cell carcinoma
\- CBC: Presence of lobule of basal cells with "palisading" on the edges, stromal reaction and dilated horizontal vessels.
Patient with squamous cell carcinoma
\- CSC: Proliferation of keratinocytes presenting cellular atypia, crossing the JDE (invasive CSC versus in situ), glomerular vessels
Patient with melanoma
Melanoma: Destructured dermal-epidermal junction (DEJ), presence of pagetoid cells, clusters of atypical melanocytes, dendritic cells
Interventions
An ex vivo examination of cutaneous resection with the OCTAV® prototype integrating the "dermoscope" function
Eligibility Criteria
Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
You may qualify if:
- Patient, male or female, at least 18 years old
- Patient with a skin lesion suspected of a cancerous pathology (basal cell carcinoma - BCC, squamous cell carcinoma - SCC and melanoma) and for whom surgery is planned at Antony Hospital
- Affiliated patient or beneficiary of a social security scheme
- Patient having signed the free and informed consent
You may not qualify if:
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
- Patient hospitalized without consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Hôpital Privé d'Antony Antony
Antony, IDF, 92160, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
DRE RAMSAYGDS
Ramsay Générale de Santé
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2022
First Posted
April 22, 2022
Study Start
December 16, 2021
Primary Completion
June 16, 2022
Study Completion
June 16, 2022
Last Updated
April 22, 2022
Record last verified: 2022-01