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Study suspended pending further funding
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vulval Disease | Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of vibrational spectroscopic techniques for differentiating key vulval tissue types |
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of vibrational spectroscopic techniques for differentiating other vulval tissue types |
| 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone vulval skin biopsy or surgery for a vulval condition within Gloucestershire Hospitals NHS Foundation Trust.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucestershire Hospitals NHS Foundation Trust | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
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Histological sections of vulval and lymph node tissue.
| ID | Term |
|---|---|
| D018459 | Lichen Sclerosus et Atrophicus |
| D002294 | Carcinoma, Squamous Cell |
| D004194 | Disease |
| D009369 | Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014845 | Vulvar Diseases |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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