Carcinoma, Basal CellNCT03482622
Intraoperative Detection of Residual BCC by Fast Raman
An observational study of Carcinoma, Basal Cell and Intraoperative BCC Detection by Fast Raman Device, run by University of Nottingham.
Trial summary
The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Basal Cell, Intraoperative BCC Detection by Fast Raman Device
- What is being tested?
- Fast Raman
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 31 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consenting patients undergoing Mohs micrographic surgery of BCC.
Who may be able to join
- Patients undergoing Mohs micrographic surgery of BCC.
- Able to give informed consent.
- Any age.
Who cannot join
- Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accurate Assessment of Tumour Clearance During Surgical Treatment of Basal Cell Carcinoma by Fast Raman Spectroscopy
The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. The device will be tested first for patients undergoing Mohs micrographic surgery, then be extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the Fast Raman device for checking the completeness of tumour removal during Mohs micrographic surgery of BCC.
Read the detailed description
Raman spectroscopy (RS) is an established analytical technique and has been extensively used in medicine to study individual cells and complex tissues, including skin and skin cancers. This technique is based on inelastic scattering of laser light following its interaction with vibrating molecules of biological samples; therefore, a Raman spectrum represents a "chemical fingerprint" of the sample. Recently, the investigators demonstrated that Raman micro-spectroscopy is able to discriminate between healthy skin and BCC.
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.
- Being tested
- Fast Raman
- Keywords
- Raman spectroscopy
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast RamanDiagnostic test
Fast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fast Raman |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
Accuracy (sensitivity/specificity) of diagnosis made by the Fast Raman device compared to frozen-section histopathology (standard practice) as a the standard of reference.
Measured: Immediate
Secondary outcomes (2)
Reliability
Intra- and inter-user variability in accuracy of Fast Raman results. Identify any conditions (patient groups, tissue types, procedural errors) that cause inaccurate diagnosis.
Measured: Immediate
Measurement Time
Evaluate whether tissue layers can be analysed faster by the Fast Raman device than normal clinical practice.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Circle Nottingham NHS Treatment Centre
- Responsible party
- Sponsor
- Investigators
- Ioan Notingher, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482622
- Sponsor's protocol ID
- 18003
- Status last verified
- Feb 2018
- First submitted
- 14 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying patient data will be stored as part of this study.
Publications
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.
PubMed 38736216
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Assessment of Tumour Clearance During Surgical Treatment of Basal Cell Carcinoma by Fast Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT03482622
- Acronym / sponsor ID
- 18003
- Keywords
- Raman spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Circle Nottingham NHS Treatment Centre
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Mar 2018 (actual)
- 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.
The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. The device will be tested first for patients undergoing Mohs micrographic surgery, then be extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the Fast Raman device for checking the completeness of tumour removal during Mohs micrographic surgery of BCC.
Detailed description
Raman spectroscopy (RS) is an established analytical technique and has been extensively used in medicine to study individual cells and complex tissues, including skin and skin cancers. This technique is based on inelastic scattering of laser light following its interaction with vibrating molecules of biological samples; therefore, a Raman spectrum represents a "chemical fingerprint" of the sample. Recently, the investigators demonstrated that Raman micro-spectroscopy is able to discriminate between healthy skin and BCC.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Mohs surgery | – | Diagnostic Test: Fast RamanSkin 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consenting patients undergoing Mohs micrographic surgery of BCC.
Key inclusion criteria (3 listed)
- Patients undergoing Mohs micrographic surgery of BCC.
- Able to give informed consent.
- Any age.
Key exclusion criteria (1 listed)
- Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast RamanFast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes. | Diagnostic test | Patients undergoing Mohs surgery |
Primary outcome
Validity
Time frame: Immediate
Accuracy (sensitivity/specificity) of diagnosis made by the Fast Raman device compared to frozen-section histopathology (standard practice) as a the standard of reference.
2 secondary outcomes
Reliability
Time frame: Immediate
Measurement Time
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 38736216Boitor 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.
- Individual participant dataSharing planned: No. No identifying patient data will be stored as part of this study.
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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.
Ioan Notingher, PhD principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Basal Cell and Intraoperative BCC Detection by Fast Raman Device, run by University of Nottingham.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ioan Notingher, PhD (0115 951 5172, ioan.notingher@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482622, which also lists 1 linked publication.
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 29 Mar 2018.