Clinical trial · Observational
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Carcinoma, Basal Cell (BCC) | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Implementation | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms, Basal Cell | Basal Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Optical Coherence Tomography (OCT) | — | UNRESOLVED | — |
| Real-world Study | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients wit BCC suspected lesions who underwent LC-OCT imaging
- description
- Patients with clinically suspected BCC lesions requiring biopsy who underwent LC-OCT imaging as part of routine clinical care at Mohs Clinics.
Primary outcomes (1)
- measure
- Tumor free survival
- timeFrame
- From enrollment to end of treatment at 6-12 months.
- description
- 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 outcomes (5)
- measure
- Diagnostic accuracy for BCC detection
- timeFrame
- From enrollment to end of treatment at 6-12 months.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available