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Optical Coherence Microscopy in Dermato-oncology (OCTAV)

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCTAV Patient
OCTAV Control group
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Cancer focused on measuring Optical biopsy, Skin cancer, Diagnostic performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

FOR PATIENT

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

Sites / Locations

  • Chu de Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OCTAV Patient

OCTAV Control group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2018
Last Updated
December 6, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
DAMAE Médical
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1. Study Identification

Unique Protocol Identification Number
NCT03731247
Brief Title
Optical Coherence Microscopy in Dermato-oncology
Acronym
OCTAV
Official Title
In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
April 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
DAMAE Médical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Optical biopsy, Skin cancer, Diagnostic performance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group of skin cancer patients One group without skin cancer patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCTAV Patient
Arm Type
Experimental
Arm Description
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)
Arm Title
OCTAV Control group
Arm Type
Experimental
Arm Description
Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
Intervention Type
Device
Intervention Name(s)
OCTAV Patient
Other Intervention Name(s)
OCTAV, DAMAE Medical, Paris, France
Intervention Description
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Intervention Type
Device
Intervention Name(s)
OCTAV Control group
Other Intervention Name(s)
OCTAV, DAMAE Medical, Paris, France
Intervention Description
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Time Frame
Day 1
Title
Specificity
Description
Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Measure of the thickness of the different skin layers (mm)
Description
Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
FOR PATIENT 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc PERROT, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optical Coherence Microscopy in Dermato-oncology

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