Normal Vulval SkinVulval VSNCT02223975
Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
An observational study of Normal Vulval Skin and Lichen Sclerosus, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Vulval Skin, Lichen Sclerosus, High Grade Dysplasia - Usual Type ('VIN 2-3')
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2018
- Phase
- Observational
- 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 16 to 120 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.
Who may be able to join
- Vulval skin tissue stored after routine histopathological analysis from women treated or investigated for a vulval skin condition.
- Inguinofemoral lymph nodes stored after routine histopathological analysis from women treated for vulval cancer.
Who cannot join
- Tissue specimens inadequate for analysis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL1 3NN
About this study
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.
Read the detailed description
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
- To establish vibrational spectral signal characteristics across a range of known vulval skin conditions.
- To evaluate the ability of vibrational spectroscopic techniques to differentiate different vulval skin conditions.
- To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in women who have undergone surgery for vulval cancer.
- To further the understanding of biochemical changes in a range of known vulval skin conditions.
- Conditions
- Normal Vulval Skin, Lichen Sclerosus, High Grade Dysplasia - Usual Type ('VIN 2-3'), High Grade Dysplasia - Differentiated Type ('VIN 2-3'), Squamous Cell Carcinoma, Epithelial Hyperplasia Without Atypia
- Keywords
- Spectrum Analysis, vibrational, Spectrum Analysis, infrared, Spectrum Analysis, Raman, Spectrum Analysis, Fourier transform infrared spectroscopy, Raman probe, Optical, Diagnosis, Cancer, Multivariate analysis, Vulval Intraepithelial Neoplasia, Vulvar Neoplasm, Vulva, Vulvar Diseases
- Medical subject headings
- Lichen Sclerosus et Atrophicus, Carcinoma, Squamous Cell, Disease, Neoplasms, Vulvar Neoplasms, Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vulval Disease | Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types
- 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
Measured: 2 years
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
Measured: 2 years
Secondary outcomes (1)
Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types
- Epithelial hyperplasia without atypia
- Atypia not otherwise specified/ Low grade dysplasia ('VIN 1')
- Pagets disease of the vulva
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion1 Aug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Study suspended pending further funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Vulval SkinStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jonathan Frost, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223975
- Sponsor's protocol ID
- 14/040/GHT
- Acronym
- Vulval VS
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2014
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Vibrational Spectroscopy in the Assessment of Vulval Disease
- ClinicalTrials.gov ID
- NCT02223975
- Acronym / sponsor ID
- Vulval VS / 14/040/GHT
- Conditions
- Normal Vulval Skin, Lichen Sclerosus, High Grade Dysplasia - Usual Type ('VIN 2-3'), High Grade Dysplasia - Differentiated Type ('VIN 2-3'), Squamous Cell Carcinoma, Epithelial Hyperplasia Without Atypia
- Keywords
- Spectrum Analysis, vibrational, Spectrum Analysis, infrared, Spectrum Analysis, Raman, Spectrum Analysis, Fourier transform infrared spectroscopy, Raman probe, Optical, Diagnosis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study suspended pending further funding
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 22 Aug 2014 (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.
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.
Detailed description
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
- To establish vibrational spectral signal characteristics across a range of known vulval skin conditions.
- To evaluate the ability of vibrational spectroscopic techniques to differentiate different vulval skin conditions.
- To evaluate the ability of vibrational spectroscopy to detect diseased lymph nodes in women who have undergone surgery for vulval cancer.
- To further the understanding of biochemical changes in a range of known vulval skin conditions.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vulval Disease | – | –Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.
Key inclusion criteria (2 listed)
- Vulval skin tissue stored after routine histopathological analysis from women treated or investigated for a vulval skin condition.
- Inguinofemoral lymph nodes stored after routine histopathological analysis from women treated for vulval cancer.
Key exclusion criteria (1 listed)
- Tissue specimens inadequate for analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types
Time frame: 2 years
* 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
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
Time frame: 2 years
Diagnostic performance of vibrational spectroscopic techniques for differentiating between normal and diseased lymph nodes in vulval carcinoma.
1 secondary outcome
Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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?
An observational study of Normal Vulval Skin and Lichen Sclerosus, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 1 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: paused, as of the sponsor's last update on 4 Aug 2017. 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 United Kingdom. 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?
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?
Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types (time frame: 2 years). The study lists 2 primary outcomes in all. 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 4 Aug 2017.