Clinical trial · Interventional
(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)
(Cost)-Effectiveness of Optical Coherence Tomography Versus Regular Punch Biopsy in the Diagnosis and Subtyping of Basal Cell Carcinoma: a Multi Center Randomized Non-inferiority Trial
NCT03848078CI-TRIAL-00050306ROCTIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC).
Conditions
Conditions (2)
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 | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Optical Coherence Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optical Coherence Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Optical Coherence Tomography arm
- description
- In the intervention arm, OCT imaging is performed which will take about 3 minutes. The decision on the most adequate treatment strategy will be based directly on the OCT diagnosis, but only when there is certainty about the presence of BCC and BCC subtype according to the OCT diagnosis. A 'safety' biopsy will be performed after the OCT scan. In patients where the OCT diagnosis leaves doubt or it is certain that there is no BCC, a biopsy will be taken anyway and the treatment decision will be based on the result of this punch biopsy.
- interventionNames
- Device: Optical Coherence Tomography
- type
- NO_INTERVENTION
- label
- Regular care arm
- description
- In patients assigned to regular care, the result of punch biopsy will always be used to decide which treatment is most adequate. Therefore, a next consultation will be planned to discuss the outcome of the biopsy and the intended treatment strategy.
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patient (\>18 years) * Clinical and dermoscopic suspicion of BCC * BCC is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions. Exclusion Criteria: * Patients with BCC in the high-risk zone of the face (ear, nose, eye region) * Patients with a large BCC referred to our (tertiary care) head and neck tumour working group.
References
Publications (4)
- BACKGROUNDFlohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T. Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol. 2011 Jan;91(1):24-30. doi: 10.2340/00015555-1009. PMID 21264452
- BACKGROUNDCheng HM, Guitera P. Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol. 2015 Dec;173(6):1371-80. doi: 10.1111/bjd.14042. Epub 2015 Oct 27. PMID 26211438
- BACKGROUNDNVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.
- DERIVEDAdan F, Nelemans PJ, Essers BAB, Brinkhuizen T, Dodemont SRP, Kessels JPHM, Quaedvlieg PJF, Dermont GJ, Winnepenninckx VJL, Abdul Hamid M, Kelleners-Smeets NWJ, Mosterd K. Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial. Lancet Oncol. 2022 Aug;23(8):1087-1096. doi: 10.1016/S1470-2045(22)00347-3. Epub 2022 Jul 11. PMID 35835136