<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223975</url>
  </required_header>
  <id_info>
    <org_study_id>14/040/GHT</org_study_id>
    <nct_id>NCT02223975</nct_id>
  </id_info>
  <brief_title>Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease</brief_title>
  <acronym>Vulval VS</acronym>
  <official_title>Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gloucestershire Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin&#xD;
      disorders are common and the diagnosis of these conditions can be difficult. Reliable&#xD;
      discrimination between benign vulval skin conditions, precancerous conditions or vulval&#xD;
      cancer often requires tissue biopsies. In addition the monitoring of patients with vulval&#xD;
      disease at risk cancerous change is currently limited to visual assessment often supplemented&#xD;
      by multiple invasive tissue biopsies. There are currently no established non invasive tests&#xD;
      available for the diagnosis of vulval skin diseases.&#xD;
&#xD;
      The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared&#xD;
      spectroscopy are non invasive diagnostic tools that use the interaction of light within&#xD;
      tissues to identify the chemical composition of different tissues. The use of these tools may&#xD;
      reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease.&#xD;
&#xD;
      The aim of this project is to explore the use of vibrational spectroscopic techniques in the&#xD;
      diagnosis of vulval skin disease. This will be achieved by performing vibrational&#xD;
      spectroscopy on samples of tissue previously taken from women with vulval skin disease&#xD;
      treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy&#xD;
      will be compared with the routine tests and the accuracy of spectroscopy determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design Ex vivo vibrational spectroscopic analysis of existing stored vulval and lymph node&#xD;
      tissue samples collected from patients who have undergone treatment for vulval disease.&#xD;
      Vibrational spectra are to be correlated with consensus histopathology and multivariate&#xD;
      analysis to be used to evaluate the classification accuracy of vibrational spectroscopy ex&#xD;
      vivo.&#xD;
&#xD;
      Aims&#xD;
&#xD;
        1. To establish vibrational spectral signal characteristics across a range of known vulval&#xD;
           skin conditions.&#xD;
&#xD;
        2. To evaluate the ability of vibrational spectroscopic techniques to differentiate&#xD;
           different vulval skin conditions.&#xD;
&#xD;
        3. To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in&#xD;
           women who have undergone surgery for vulval cancer.&#xD;
&#xD;
        4. To further the understanding of biochemical changes in a range of known vulval skin&#xD;
           conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study suspended pending further funding&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types</measure>
    <time_frame>2 years</time_frame>
    <description>Normal vulval skin&#xD;
Lichen Sclerosus&#xD;
High grade dysplasia - Usual type ('Vulval Intraepithelial Neoplasia 2-3')&#xD;
High grade dysplasia - Differentiated type ('Vulval Intraepithelial Neoplasia 2-3')&#xD;
Squamous cell carcinoma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.</measure>
    <time_frame>2 years</time_frame>
    <description>Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types</measure>
    <time_frame>2 years</time_frame>
    <description>Epithelial hyperplasia without atypia&#xD;
Atypia not otherwise specified/ Low grade dysplasia ('VIN 1')&#xD;
Pagets disease of the vulva</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Normal Vulval Skin</condition>
  <condition>Lichen Sclerosus</condition>
  <condition>High Grade Dysplasia - Usual Type ('VIN 2-3')</condition>
  <condition>High Grade Dysplasia - Differentiated Type ('VIN 2-3')</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <condition>Epithelial Hyperplasia Without Atypia</condition>
  <condition>Atypia Not Otherwise Specified/ Low Grade Dysplasia ('VIN 1')</condition>
  <condition>Pagets Disease of the Vulva</condition>
  <arm_group>
    <arm_group_label>Vulval Disease</arm_group_label>
    <description>Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Histological sections of vulval and lymph node tissue.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone vulval skin biopsy or surgery for a vulval condition within&#xD;
        Gloucestershire Hospitals NHS Foundation Trust.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Vulval skin tissue stored after routine histopathological analysis from women treated&#xD;
             or investigated for a vulval skin condition.&#xD;
&#xD;
          -  Inguinofemoral lymph nodes stored after routine histopathological analysis from women&#xD;
             treated for vulval cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tissue specimens inadequate for analysis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Gloucester</city>
        <state>Gloucestershire</state>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gloucestershire Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dr Jonathan Frost</investigator_full_name>
    <investigator_title>Clinical Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Spectrum Analysis, vibrational</keyword>
  <keyword>Spectrum Analysis, infrared</keyword>
  <keyword>Spectrum Analysis, Raman</keyword>
  <keyword>Spectrum Analysis</keyword>
  <keyword>Fourier transform infrared spectroscopy</keyword>
  <keyword>Raman probe</keyword>
  <keyword>Optical</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Cancer</keyword>
  <keyword>Multivariate analysis</keyword>
  <keyword>Vulval Intraepithelial Neoplasia</keyword>
  <keyword>Vulvar Neoplasm</keyword>
  <keyword>Vulva</keyword>
  <keyword>Vulvar Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Sclerosus et Atrophicus</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223975
org study id: 14/040/GHT
nct id: NCT02223975
lead sponsor: 
has dmc: No
Can vibrational spectroscopy be used to accurately assess vulval skin conditions? Vulval skin
      disorders are common and the diagnosis of these conditions can be difficult. Reliable
      discrimination between benign vulval skin conditions, precancerous conditions or vulval
      cancer often requires tissue biopsies. In addition the monitoring of patients with vulval
      disease at risk cancerous change is currently limited to visual assessment often supplemented
      by multiple invasive tissue biopsies. There are currently no established non invasive tests
      available for the diagnosis of vulval skin diseases.

      The vibrational spectroscopic techniques of Raman spectroscopy and Fourier transform infrared
      spectroscopy are non invasive diagnostic tools that use the interaction of light within
      tissues to identify the chemical composition of different tissues. The use of these tools may
      reduce the need for invasive biopsies to diagnose and monitor women with vulval skin disease.

      The aim of this project is to explore the use of vibrational spectroscopic techniques in the
      diagnosis of vulval skin disease. This will be achieved by performing vibrational
      spectroscopy on samples of tissue previously taken from women with vulval skin disease
      treated at Gloucestershire Hospitals NHS Foundation Trust. The results of the spectroscopy
      will be compared with the routine tests and the accuracy of spectroscopy determined.
Design Ex vivo vibrational spectroscopic analysis of existing stored vulval and lymph node
      tissue samples collected from patients who have undergone treatment for vulval disease.
      Vibrational spectra are to be correlated with consensus histopathology and multivariate
      analysis to be used to evaluate the classification accuracy of vibrational spectroscopy ex
      vivo.

      Aims

        1. To establish vibrational spectral signal characteristics across a range of known vulval
           skin conditions.

        2. To evaluate the ability of vibrational spectroscopic techniques to differentiate
           different vulval skin conditions.

        3. To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in
           women who have undergone surgery for vulval cancer.

        4. To further the understanding of biochemical changes in a range of known vulval skin
           conditions.
observational model: Case-Only
time perspective: Other
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types
time frame: 2 years
description: Normal vulval skin
Lichen Sclerosus
High grade dysplasia - Usual type ('Vulval Intraepithelial Neoplasia 2-3')
High grade dysplasia - Differentiated type ('Vulval Intraepithelial Neoplasia 2-3')
Squamous cell carcinoma
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
time frame: 2 years
description: Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
measure: Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types
time frame: 2 years
description: Epithelial hyperplasia without atypia
Atypia not otherwise specified/ Low grade dysplasia ('VIN 1')
Pagets disease of the vulva
arm group label: Vulval Disease
description: Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.
Histological sections of vulval and lymph node tissue.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Gloucestershire Hospitals NHS Foundation Trust
investigator full name: Dr Jonathan Frost
investigator title: Clinical Research Fellow
mesh term: Lichen Sclerosus et Atrophicus
mesh term: Hyperplasia