(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)

Not Applicable

• Conditions: Basal Cell Carcinoma; Optical Coherence Tomography
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT03848078
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-02-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-08-31
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 598

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography arm	Optical Coherence Tomography	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.

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness of OCT	12 months	The main endpoint for the cost-effectiveness analysis is the Incremental Cost-Effectiveness Ratio (ICER) defined as extra cost per gained Quality-Adjusted Life Year (QALY).
Proportion of patients with treatment failure	12 months	The main endpoint for the non-inferiority trial is the proportion of patients with treatment failure after 12 months follow-up, where treatment failure is defined as inadequate treatment or recurrence of malignant or premalignant lesions.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with avoided biopsies	12 months	What percentage of biopsies can be avoided in patients when using optical coherence tomography compared to regular care.
Diagnostic performance of OCT	12 months	The design of the study also enables evaluation of the ability of OCT to discriminate between BCC and non-BCC and between BCC subtypes (superficial, nodular and infiltrative BCC) using punch biopsy as reference standard. Diagnostic performance will be expressed as sensitivity, specificity, positive and negative predictive value. A receiver operating characteristic (ROC) curve with area under the curve (AUC) will also be calculated.
Discrete Choice Experiment to determine patient preferences	2 months	Patient preferences will be assessed by designing and conducting a discrete choice experiment.
Quality of life measured with EQ-5D-5L	Baseline, 12 months	Quality of life will be evaluated using the 5-level EQ-5D version (EQ-5D-5L) questionnaire.

Trial Locations

Locations (1)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands