Optical Coherence Microscopy in Dermato-oncology

NCT03731247 | Completed

• 2 other identifiers: 18CH0712018-A02012-53
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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).

Conditions

Skin Cancer

Keywords

Optical biopsy; Skin cancer; Diagnostic performance

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

  Day 1

• Specificity

  Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

  Day 1

Secondary Outcomes (1)

• Measure of the thickness of the different skin layers (mm)

  Day 1

Study Arms (2)

OCTAV Patient

EXPERIMENTAL

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)

Device: OCTAV Patient

OCTAV Control group

EXPERIMENTAL

Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Device: OCTAV Control group

Interventions

OCTAV Patient DEVICE

In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.

Also known as: OCTAV, DAMAE Medical, Paris, France

OCTAV Patient

OCTAV Control group DEVICE

In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.

Also known as: OCTAV, DAMAE Medical, Paris, France

OCTAV Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Aged between 18 to 40 years
• Consent form signed
• Patient of the dermatology department with non-pathological forearm skin
• Allergy or intolerance to immersion oil (used for microscopy)
• If female, pregnant or breast-feeding
• Patient unable to stand still for 60 seconds

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• DAMAE Médical: collaborator

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Luc PERROT, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of skin cancer patients One group without skin cancer patients

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 6, 2018
• Study Start: October 19, 2018
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)