Clinical trial NCT03848078: (Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)
Official title: (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Optical Coherence Tomography
Keywords: Basal Cell Carcinoma
Optical Coherence Tomography
Punch biopsy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2019-02-20
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre randomised controlled non-inferiority trial
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: Skin cancer incidence rises worldwide due to high sun exposure and ageing. Basal cell carcinoma (BCC) is the most prevalent form, with a lifetime risk of 16-20% in the Netherlands. Currently, the gold standard for diagnosing and subtyping BCC is a punch biopsy. Since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (OCT). In patients with clinical and dermoscopic suspicion of BCC, OCT makes it possible to confirm and subtype BCC with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. Hence, BCC diagnosis and treatment can be accomplished in one day. As a result, patients experience less distress and costs can be saved. By discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. The investigators hypothesize that the use of OCT is a cost-effective strategy when compared to regular care (always punch biopsy). However, it is important to evaluate whether an alternative OCT guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent BCC.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with treatment failure
timeFrame: 12 months
measure: Cost-effectiveness of OCT
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of patients with avoided biopsies
timeFrame: 12 months
measure: Diagnostic performance of OCT
timeFrame: 12 months
measure: Discrete Choice Experiment to determine patient preferences
timeFrame: 2 months
measure: Quality of life measured with EQ-5D-5L
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Klara Mosterd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flohil 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.
citation: Cheng 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.
citation: NVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.
citation: Adan 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.