Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2018-04-01
2023-03-31
Brief Summary
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Detailed Description
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With National Institute for Health Research (NIHR) i4i funding (2007-2013), the investigators developed a new technology ("Fast Raman") that can detect BCC regions in skin layers excised during Mohs surgery \[13\]. A first laboratory prototype based on this technology was able to analyze specimens in 30-60 minutes. In a follow-up i4i project (2014-2016), the investigators have built a fully automated "Fast Raman" device that can be used by non-specialist users and meets the safety requirements to be used in the clinic. The investigators now intend to test this device in real clinical practice and to compare the diagnosis generated by the device with the standard pathology diagnosis.
If the performance of the device achieves the proposed target (\~95% sensitivity and specificity, inter-and intra-user reliability higher than typical histopathology, assessment time shorter than frozen section histopathology), it will provide important benefit to BCC patients and health care providers. Faster tissue assessment could speed up Mohs surgery (around 90 mins rather than 3 hours), which is more comfortable for patients. By reducing the costly histopathology procedures needed to process and diagnose skin samples, the Fast Raman device will reduce health care costs, allowing Mohs surgery to become more widely available, and reducing the postcode lottery that currently exists. As the Fast Raman device is designed to be used by non-specialist user, it can be used during any type of BCC surgery, including standard wide local excisions of BCC (\>80,000 procedures/year in UK), to provide on the spot an answer on whether the entire tumour has been excised or not.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Patients undergoing Mohs surgery
Skin samples excised during Mohs surgery will be measured by the Fast Raman device. The Fast Raman measurements will be compared to gold standard histopathology to determine measurement accuracy.
Fast Raman
Fast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes.
Interventions
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Fast Raman
Fast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent.
* Any age.
Exclusion Criteria
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Circle Nottingham NHS Treatment Centre
UNKNOWN
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Ioan Notingher, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Central Contacts
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References
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Boitor RA, Varma S, Sharma A, Odedra S, Elsheikh S, Eldib K, Patel A, Koloydenko A, Gran S, De Winne K, Koljenovic S, Williams HC, Notingher I. Diagnostic accuracy of autofluorescence-Raman microspectroscopy for surgical margin assessment during Mohs micrographic surgery of basal cell carcinoma. Br J Dermatol. 2024 Aug 14;191(3):428-436. doi: 10.1093/bjd/ljae196.
Other Identifiers
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18003
Identifier Type: -
Identifier Source: org_study_id
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