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The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis (DATRIV)

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ClinicalTrials.gov Identifier: NCT02732145
Recruitment Status : Unknown
Verified September 2016 by Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni.
Recruitment status was:  Recruiting
First Posted : April 8, 2016
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
Klinički Bolnički Centar Zagreb
University of Zagreb
Information provided by (Responsible Party):
Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni

Brief Summary:
To determine the sensitivity and specificity of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.

Condition or disease Intervention/treatment
Lichen Sclerosus Lichen Planus Lichen Simplex Chronicus Vulvodynia Other: ISSVD Questionnaire Procedure: Three Rings Vulvoscopy Procedure: Histopathology

Detailed Description:

In order to ensure a more accurate and systematic mapping of vulvar lesions, we previously described the original technique for performing colposcopy of the vulva called "Three Rings Vulvoscopy", taking into account three different skin types and zones, as well as morphological evaluation of lesions according to their specificity (non-specific and specific lesions).

As the new colposcopy technique seemed to be promising in the differential diagnosis of vulvar discomfort, we designed two index tests, a semi-quantitative test called "N-S-P scheme" and a quantitative test named "Vulvoscopy Index".

The sensitivity and specificity of both index tests will be estimated in comparison with histopathology as the reference test in two groups of asymptomatic patients ("normal vulva" - without any colposcopy lesion and "impaired vulvar skin" - with non-specific lesion) and in two groups of symptomatic patients ("vulvodynia" and "vulvar dermatosis") at the end of the study.

Vulvar discomfort and lesions are being assessed and measured with "ISSVD Vulvodynia Pattern Questionnaire" and "TRIV Form Data".

Asymptomatic patients are being recruited from asymptomatic patients undergoing planned labiaplasty, who grant vulvar samples to further investigation. Biopsy of the vulva from the symptomatic patients is being done during the routine clinical care.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
Study Start Date : December 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Group/Cohort Intervention/treatment
Normal vulva

Patients without vulvar discomfort and without any vulvar lesion undergoing planned labiaplasty, prior to surgery.

ISSVD Questionnaire, Three Rings Vulvoscopy, Histopathology.

Other: ISSVD Questionnaire
Questionnaire: Patient characteristics, symptoms description, other conditions..
Other Name: ISSVD Vulvodynia Pattern Questionnaire

Procedure: Three Rings Vulvoscopy
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during colposcopy examination of the vulva using "Three Rings Vulvoscopy" technique (TRIV Form Data).
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the vulva

Impaired vulvar skin

Patients without vulvar symptoms with some lesions of the vulva undergoing planned labiaplasty, prior to surgery.

ISSVD Questionnaire, Three Rings Vulvoscopy, Histopathology.

Other: ISSVD Questionnaire
Questionnaire: Patient characteristics, symptoms description, other conditions..
Other Name: ISSVD Vulvodynia Pattern Questionnaire

Procedure: Three Rings Vulvoscopy
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during colposcopy examination of the vulva using "Three Rings Vulvoscopy" technique (TRIV Form Data).
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the vulva

Vulvodynia

Patients with vulvar discomfort especially pain, without specific lesions of the vulva.

ISSVD Questionnaire, Three Rings Vulvoscopy, Histopathology.

Other: ISSVD Questionnaire
Questionnaire: Patient characteristics, symptoms description, other conditions..
Other Name: ISSVD Vulvodynia Pattern Questionnaire

Procedure: Three Rings Vulvoscopy
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during colposcopy examination of the vulva using "Three Rings Vulvoscopy" technique (TRIV Form Data).
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the vulva

Vulvar dermatosis

Patients with vulvar discomfort and specific lesions of the vulva (lesions specific for vulvar dermatosis).

ISSVD Questionnaire, Three Rings Vulvoscopy, Histopathology.

Other: ISSVD Questionnaire
Questionnaire: Patient characteristics, symptoms description, other conditions..
Other Name: ISSVD Vulvodynia Pattern Questionnaire

Procedure: Three Rings Vulvoscopy
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during colposcopy examination of the vulva using "Three Rings Vulvoscopy" technique (TRIV Form Data).
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the vulva




Primary Outcome Measures :
  1. The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis. [ Time Frame: up to five years ]
    Sensitivity, specificity and accuracy of the "Three-Rings Vulvoscopy" (TRIV) for detection of vulvar dermatosis assessed with two index tests, "N-S-P scheme" and "Vulvoscopy Index" in comparison to histopathology as the "golden standard" (reference test).


Secondary Outcome Measures :
  1. Epidemiological characteristics of the patients with and without vulvar discomfort. [ Time Frame: up to five years ]
    Demographic data, characteristics of the symptoms and other conditions in patients with and without vulvar discomfort assessed with "International Society for Study of Vulvovaginal Diseases (ISSVD) Vulvodynia Pattern Questionnaire".

  2. Distribution of colposcopy lesions of the vulva in patients with and without vulvar discomfort according to the three vulvar rings and their specificity. [ Time Frame: up to five years ]
    Distribution of non-specific and specific colposcopy lesions according to the three vulvar rings in patients with and without vulvar discomfort assessed with "TRIV Form Data".

  3. Aceto-whitening pattern in patients with vulvodynia and vulvar dermatosis according to the three vulvar rings. [ Time Frame: up to five years ]
    Aceto-acid test, the aceto-whitening pattern according to the three vulvar rings and the reaction time in different groups, assessed with "TRIV Form Data".


Biospecimen Retention:   Samples With DNA
Vulvar samples for histopathological analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with vulvar discomfort recruited in colposcopy unit in "Poliklinika Harni", a secondary care gynecologic clinic in Zagreb.

Patients without vulvar discomfort recruited from the group of patients undergoing planned labiaplasty, at the same location.

Criteria

Inclusion Criteria:

"Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December 2016.

Ability to provide Informed Consent and complete Questionnaire.

Exclusion Criteria:

Incomplete medical records. Lack of histopathology. Vulvo-vaginal infection. Benign tumors of the vulva. Pre-/malignant conditions of the vulva.


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): NCT02732145


Contacts
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Contact: Vesna Harni, MD 0038512923648 vesnaharni@gmail.com

Locations
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Croatia
Poliklinika Harni Recruiting
Zagreb, Croatia, HR-10000
Contact: Vesna Harni, MD    00385989544501    vesnaharni@gmail.com   
Principal Investigator: Vesna Harni, MD         
Sub-Investigator: Damir Babic, MD         
Sub-Investigator: Suzana Ljubojevic-Hadziavdic, MD         
Sponsors and Collaborators
Ginekološka Poliklinika Dr. Vesna Harni
Klinički Bolnički Centar Zagreb
University of Zagreb
Investigators
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Principal Investigator: Vesna Harni, MD Poliklinika Harni, Bukovacka 1, HR-10000 Zagreb, Croatia

Study Data/Documents: Observational study  This link exits the ClinicalTrials.gov site
Harni V, Babic D, Barisic D. "Three Rings Vulvoscopy" - A New Approach to the Vulva. Gynaecol Perinatol 2015; 24 (1):37-45

Publications:

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Responsible Party: Vesna Harni, Dr. med. Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni
ClinicalTrials.gov Identifier: NCT02732145     History of Changes
Other Study ID Numbers: PH20111201001
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni:
Vulvar Lichen Sclerosus
Three-Vulvar-Rings
Three-Rings-Vulvoscopy
N-S-P scheme
Vulvoscopy Index
Vulvar Dermatosis
Lichen Planus
Lichen Simplex Chronicus
Vulvodynia
Provoked Vestibulodynia
Vulvar Vestibulitis
Vulvar Diseases
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Vulvodynia
Lichen Planus
Skin Diseases
Neurodermatitis
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Vulvar Diseases
Genital Diseases, Female
Dermatitis
Skin Diseases, Eczematous