Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms, Neoplasms, Basal Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study
Overview
Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions. This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.
Detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer in the Netherlands, with its incidence having increased substantially in recent years. ). Over the past decades, non-invasive imaging techniques such as line-field confocal optical coherence tomography (LC-OCT) have emerged as promising alternatives to biopsy for the diagnosis of BCC. When BCC can be diagnosed with high confidence using (LC-)OCT, this may reduce the need for biopsies, accelerate treatment initiation, and improve healthcare efficiency. LC-OCT combines the principles of conventional optical coherence tomography (OCT) and reflectance confocal microscopy (RCM), enabling three-dimensional visualization of the skin at a cellular resolution.
Several studies have reported a high specificity of LC-OCT for identifying non-BCC lesions, ranging from 97-99%. In cases where BCC can be diagnosed with high confidence, biopsy may theoretically be omitted, meaning that treatment could be initiated promptly. Reported sensitivities for such "high-confidence" BCC diagnoses range from 95-100%.
Although the diagnostic accuracy of LC-OCT has been investigated extensively in research settings, evidence on its real-world clinical performance remains limited. This retrospective study aims to evaluate the clinical utility of LC-OCT in routine dermatological practice.
Primary outcome measures
- Tumor free survival [Time frame: From enrollment to end of treatment at 6-12 months.]
Secondary outcome measures (5)
- Diagnostic accuracy for BCC detection [Time frame: From enrollment to end of treatment at 6-12 months.]
- Treatment strategies [Time frame: From enrollment to end of treatment at 6-12 months.]
- Number of performed LC-OCT scans [Time frame: From enrollment to 6-12 months]
- Lesion characteristics [Time frame: At baseline]
- Proportion of biopsies omitted [Time frame: From enrollment to end of treatment at 6-12 months.]
Eligibility criteria
Inclusion criteria
- Patients aged ≥18 years
- LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands
- Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available
Exclusion criteria
- Patients <18 years of age
- Cases without histopathological confirmation or available follow-up data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Maastricht University Medical Center + — Maastricht
Identifiers
NCT: NCT07501780 · METC2025-0250