Basal Cell Carcinoma of Skin, Carcinoma, Basal Cell (BCC), Implementation, Neoplasms, Neoplasms, Basal Cell, Optical Coherence Tomography (OCT), Real-world Study
Conditions
Keywords
Line-Field Optical Coherence Tomography, Real-world evaluation, Non-melanoma skin cancer
Brief summary
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.
Interventions
None listed
Sponsors
Maastricht University Medical Center
Mohs Klinieken
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor free survival | From enrollment to end of treatment at 6-12 months. | Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy for BCC detection | From enrollment to end of treatment at 6-12 months. | Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio) will be estimated for diagnosis made by LC-OCT (with histopathology serving as reference standard). |
| Treatment strategies | From enrollment to end of treatment at 6-12 months. | Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical). |
| Number of performed LC-OCT scans | From enrollment to 6-12 months | Descriptive evaluation: number of LC-OCT scans performed |
| Lesion characteristics | At baseline | Descriptive: lesion characteristics (size, location) |
| Proportion of biopsies omitted | From enrollment to end of treatment at 6-12 months. | Proportion of biopsies omitted |
Countries
Netherlands
Contacts
CONTACTYara Valkenburg, MD
CONTACTKlara Mosterd, MD PhD
Outcome results
None listed