Basal Cell CarcinomaNCT06273709
Remote Assessment of OCT Scans for BCC Detection
An observational study of Basal Cell Carcinoma, run by Maastricht University Medical Center.
Trial summary
Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Included cases contain OCT scans of patients with lesions suspect for BCC. Three OCT assessors will be included in this study to assess the OCT scans with and without clinical and dermoscopic photographs.
Who may be able to join
- 18+ years of age
- Underwent OCT scan and punch biopsy for lesions suspect for BCC
Who cannot join
- Unable to sign informed consent
Trial locations and contacts
No sites are listed yet.
Klara Mosterd, MD PhD contact
About this study
Official title: The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control Study
Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).
- Conditions
- Basal Cell Carcinoma
- Being tested
- Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner
- Keywords
- Basal cell carcinoma, Optical coherence tomography, Imaging, Non-melanoma skin cancer
- 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.
Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerDevice
(Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm).
| Study group | Role | What they receive |
|---|---|---|
| OCT scans without clinical/dermoscopic photographs | OCT scans will be used from a pre-existing registry. The OCT scans are made of lesions clinically suspect for BCC. All patients underwent punch biopsy conform regular care. Receives: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner | |
| OCT scans with clinical/dermoscopic photographs | The same OCT scans will be used . OCT assessment is performed in conjunction with clinical and dermoscopic photographs. Receives: Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs
Diagnostic accuracy of a high confidence diagnosis (confidence-score 4) will be expressed by diagnostic parameters, such as sensitivity, specificity, positive predictive value (PPV), negative predicitive value (NPV), and diagnostic odds ratios (DOR) with 95% confidence intervals. The primary outcome in this study is specificity of a high confidence diagnosis, defined as the proportion of histological non-BCC lesions that are classified as non-BCC on OCT.
Measured: Measured before December 31st 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (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 Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273709
- Sponsor's protocol ID
- 2023-3698
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared upon reasonable request.
Publications
Wolswijk T, Nelemans PJ, van Leersum F, Cruts E, Gerarda Moermans MM, Vreven L, Hillen LM, Mosterd K. The Impact of Clinical and Dermoscopic Photographs on the Diagnostic Accuracy of Remote Optical Coherence Tomography Assessment for Basal Cell Carcinoma Detection: A Comparative Diagnostic Study. Int J Dermatol. 2026 Jun;65(6):1231-1237. doi: 10.1111/ijd.70189. Epub 2025 Dec 10.
PubMed 41373084
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control Study
- ClinicalTrials.gov ID
- NCT06273709
- Acronym / sponsor ID
- 2023-3698
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal cell carcinoma, Optical coherence tomography, Imaging, Non-melanoma skin cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT scans without clinical/dermoscopic photographs | – | Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerOCT scans will be used from a pre-existing registry. The OCT scans are made of lesions clinically suspect for BCC. All patients underwent punch biopsy conform regular care. |
| OCT scans with clinical/dermoscopic photographs | – | Device: Vivosight Multi-beam Swept-Source Frequency Domain OCT scannerThe same OCT scans will be used . OCT assessment is performed in conjunction with clinical and dermoscopic photographs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Included cases contain OCT scans of patients with lesions suspect for BCC. Three OCT assessors will be included in this study to assess the OCT scans with and without clinical and dermoscopic photographs.
Key inclusion criteria (2 listed)
- 18+ years of age
- Underwent OCT scan and punch biopsy for lesions suspect for BCC
Key exclusion criteria (1 listed)
- Unable to sign informed consent
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 |
|---|---|---|
| Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner(Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). | Device | OCT scans with clinical/dermoscopic photographs, OCT scans without clinical/dermoscopic photographs |
Primary outcome
Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs
Time frame: Measured before December 31st 2024
Diagnostic accuracy of a high confidence diagnosis (confidence-score 4) will be expressed by diagnostic parameters, such as sensitivity, specificity, positive predictive value (PPV), negative predicitive value (NPV), and diagnostic odds ratios (DOR) with 95% confidence intervals. The primary outcome in this study is specificity of a high confidence diagnosis, defined as the proportion of histological non-BCC lesions that are classified as non-BCC on OCT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41373084Wolswijk T, Nelemans PJ, van Leersum F, Cruts E, Gerarda Moermans MM, Vreven L, Hillen LM, Mosterd K. The Impact of Clinical and Dermoscopic Photographs on the Diagnostic Accuracy of Remote Optical Coherence Tomography Assessment for Basal Cell Carcinoma Detection: A Comparative Diagnostic Study. Int J Dermatol. 2026 Jun;65(6):1231-1237. doi: 10.1111/ijd.70189. Epub 2025 Dec 10.
- Individual participant dataSharing planned: Undecided. Data may be shared upon reasonable request.
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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.
Klara Mosterd, MD PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Maastricht University Medical Center.
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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. 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 Tom Wolswijk, MD MSc (+31(0)43- 387 7295, tom.wolswijk@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs (time frame: Measured before December 31st 2024). 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 NCT06273709, 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 22 Feb 2024.