Vulvar Mucosa LesionsNCT02735109
Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
A study testing photographies and biopsy normal area in people with Vulvar Mucosa Lesions and Vulvar Intraepithelial Neoplasia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Mucosa Lesions, Vulvar Intraepithelial Neoplasia
- What is being tested?
- photographies and biopsy normal area
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
The squamous cell carcinoma is the most common cancer of the vulva (90-95%), with a prognosis depending on the stage. The management of vulvar intraepithelial neoplasia (VIN) is a secondary prevention of squamous cell carcinoma of the vulva.
Conventional VIN strongly associated with infection with oncogenic HPV (human papillomavirus) , present a risk of malignant degeneration of the order of 9-15%. Whereas the differentiated VIN, rarer often seen in the context of lichen sclerosis have a high risk of malignant degeneration ranging from 40 to 50%.
The diagnosis is histological, biopsy realization is currently the gold standard before starting a cure. However, biopsies on the vulva are not a harmless act for patients, and are often repeated due to extensive damage. The early management of lesions VIN avoids changes in squamous cell carcinoma. Over their diagnosed early, the better the care and specific treatments allocated.
The confocal microscope is a new imaging technology, already widely used for examination of the skin and mucous membranes. This 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. The device will be used for this study is the VivaScope 3000.
The advantage of the confocal microscope to discriminate between benign and malignant lesions of the skin and the oral mucosa has been shown in several prospective studies. Two recent studies have highlighted the promising results of the use of the confocal microscope for pigmented vulvar lesions (melanosis / melanoma).
There is currently no data in the literature on the impact of this technique on the VIN and vulvar epidermoid carcinomas.
This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology, to prove the contribution of the confocal microscope in vulvar intraepithelial neoplasia (VIN) and vulvar epidermoid carcinomas.
The aim of the study is to describe the characteristics reproducibly confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.
The patients seen in consultation in the obstetrics and gynecology department and / or dermatology with a bow or vulvar lesions suspicious looking will be included in the study after signing an informed consent.
The results will be compared systematically to the histological results of biopsies of lesions (gold standard).
The investigators expect for this study a validation of the confocal microscope as a noninvasive diagnostic tool suspicious vulvar lesions (reduction of repeated biopsies, targeted biopsies to monitor certain lesions, and this even reduce health costs inherent to unnecessary biopsies)....
- Being tested
- photographies, biopsy normal area
- Keywords
- VIN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photographiesOther
cells description by taken photographies vith confocal microscope (VivaScope 3000)
biopsy normal areaProcedure or surgery
biopsy done to compare with abnormal area
| Study group | Role | What they receive |
|---|---|---|
| description | Other | photographies and biopsy on normal area Receives: Other: photographies; Procedure: biopsy normal area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: significant results after inclusion of 10 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Mucosa LesionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735109
- Sponsor's protocol ID
- 14-AOI-13
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2015
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors
- ClinicalTrials.gov ID
- NCT02735109
- Acronym / sponsor ID
- 14-AOI-13
- Keywords
- VIN
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: significant results after inclusion of 10 patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The squamous cell carcinoma is the most common cancer of the vulva (90-95%), with a prognosis depending on the stage. The management of vulvar intraepithelial neoplasia (VIN) is a secondary prevention of squamous cell carcinoma of the vulva.
Conventional VIN strongly associated with infection with oncogenic HPV (human papillomavirus) , present a risk of malignant degeneration of the order of 9-15%. Whereas the differentiated VIN, rarer often seen in the context of lichen sclerosis have a high risk of malignant degeneration ranging from 40 to 50%.
The diagnosis is histological, biopsy realization is currently the gold standard before starting a cure. However, biopsies on the vulva are not a harmless act for patients, and are often repeated due to extensive damage. The early management of lesions VIN avoids changes in squamous cell carcinoma. Over their diagnosed early, the better the care and specific treatments allocated.
The confocal microscope is a new imaging technology, already widely used for examination of the skin and mucous membranes. This 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. The device will be used for this study is the VivaScope 3000.
The advantage of the confocal microscope to discriminate between benign and malignant lesions of the skin and the oral mucosa has been shown in several prospective studies. Two recent studies have highlighted the promising results of the use of the confocal microscope for pigmented vulvar lesions (melanosis / melanoma).
There is currently no data in the literature on the impact of this technique on the VIN and vulvar epidermoid carcinomas.
This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology, to prove the contribution of the confocal microscope in vulvar intraepithelial neoplasia (VIN) and vulvar epidermoid carcinomas.
The aim of the study is to describe the characteristics reproducibly confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma.
The patients seen in consultation in the obstetrics and gynecology department and / or dermatology with a bow or vulvar lesions suspicious looking will be included in the study after signing an informed consent.
The results will be compared systematically to the histological results of biopsies of lesions (gold standard).
The investigators expect for this study a validation of the confocal microscope as a noninvasive diagnostic tool suspicious vulvar lesions (reduction of repeated biopsies, targeted biopsies to monitor certain lesions, and this even reduce health costs inherent to unnecessary biopsies)....
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| description | Other | Other: photographies, Procedure: biopsy normal areaphotographies and biopsy on normal area |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photographiescells description by taken photographies vith confocal microscope (VivaScope 3000) | Other | description |
| biopsy normal areabiopsy done to compare with abnormal area | Procedure or surgery | description |
Primary outcome
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope
Time frame: 12 months
2 secondary outcomes
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method
Time frame: 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
Time frame: 12 months
Results and safety
The study was stopped early (reason given: significant results after inclusion of 10 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photographies and biopsy normal area in people with Vulvar Mucosa Lesions and Vulvar Intraepithelial Neoplasia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: significant results after inclusion of 10 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.