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Optical Coherence Microscopy in Dermato-oncology (OCTAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731247
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
DAMAE Médical
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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).

Condition or disease Intervention/treatment Phase
Skin Cancer Device: OCTAV Patient Device: OCTAV Control group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group of skin cancer patients One group without skin cancer patients
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Actual Study Start Date : October 19, 2018
Actual Primary Completion Date : April 21, 2021
Actual Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Device: OCTAV Patient
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Other Name: OCTAV, DAMAE Medical, Paris, France
Experimental: OCTAV Control group
Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)
 Device: OCTAV Control group
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
Other Name: OCTAV, DAMAE Medical, Paris, France


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 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)

  2. Specificity [ Time Frame: 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 :
  1. Measure of the thickness of the different skin layers (mm) [ Time Frame: Day 1 ]
    Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731247


Locations
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France
Chu de Saint Etienne
Saint Etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
DAMAE Médical
Investigators
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Principal Investigator: Jean-Luc PERROT, MD CHU SAINT ETIENNE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03731247    
Other Study ID Numbers: 18CH071
2018-A02012-53 ( Other Identifier: ANSM )
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Optical biopsy
Skin cancer
Diagnostic performance
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases