Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors

NCT02735109 | Terminated

• 1 other identifier: 14-AOI-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as "optical" cuts in three dimensions in the thickness of the skin. This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology. The aim of the study is to describe the characteristics reproducibly for confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma. The patients seen in consultation with vulvar lesions suspicious looking will be included. The results will be compared systematically to the histological results of biopsies of lesions (gold standard).

Conditions

Vulvar Mucosa Lesions; Vulvar Intraepithelial Neoplasia

Keywords

VIN

Outcome Measures

Primary Outcomes (1)

• Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope

  12 months

Secondary Outcomes (2)

• Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method

  12 months

• Caracteristics of thorny layer, of granular layer,of basal layer of vulvar mucosa lesions VIN to descriptions and the observations of with the normal mucosa

  12 months

Study Arms (1)

description

OTHER

photographies and biopsy on normal area

Other: photographies; Procedure: biopsy normal area

Interventions

photographies OTHER

cells description by taken photographies vith confocal microscope (VivaScope 3000)

description

biopsy normal area PROCEDURE

biopsy done to compare with abnormal area

description

Eligibility Criteria

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

You may qualify if:

• Age = 18 years, Female
• Patient seen in consultation in the service of gynecology obstetrics, and, of dermatology of the Bow presenting during the medical examination one or several suspicious-looking vulvar hurts, suggestive of hurts of VIN or of carcinoma epidermoid vulvar
• Membership health secure
• Informed consent and paper of the obtained patient

You may not qualify if:

• Patient having already received a local treatment(processing) for hurts of VIN
• Pregnant Woman
• Patient under guardianship
• Not signature of the written consent and/or mental deficiency of the subject making its participation on approval impossible

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06200, France

Location

MeSH Terms

Interventions

Photography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 12, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

FR (1)