Optical Coherence Microscopy in Dermato-oncology

Not Applicable

Completed

• Conditions: Skin Cancer
• Interventions: Device: OCTAV Patient; Device: OCTAV Control group

• Registration Number: NCT03731247
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Detailed Description

At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Study Timeline

• Study Start: 2018-10-19
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
• Consent form signed
• Major patient

Exclusion Criteria

• Allergy or intolerance to immersion oil (used for microscopy)
• If female, pregnant or breast-feeding
• Patient unable to stand still for 60 seconds
• Skin lesions located near patient eyes (<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

• Aged between 18 to 40 years
• Consent form signed
• Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

• Allergy or intolerance to immersion oil (used for microscopy)
• If female, pregnant or breast-feeding
• Patient unable to stand still for 60 seconds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCTAV Patient	OCTAV Patient	The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
OCTAV Control group	OCTAV Control group	Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Primary Outcome Measures

Name	Time	Method
Sensitivity	Day 1	Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Specificity	Day 1	Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

Secondary Outcome Measures

Name	Time	Method
Measure of the thickness of the different skin layers (mm)	Day 1	Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France