Basal Cell Carcinoma, Optical Coherence Tomography
Conditions
Keywords
Basal Cell Carcinoma, Optical Coherence Tomography, Punch biopsy
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.
Interventions
DEVICEOptical Coherence Tomography
OCT is an imaging technique, which is able to produce real-time, in vivo, cross-sectional images of lesions with a depth of 1,5-2 mm. OCT imaging is based on light-interferometry, calculating the interference of an optical beam reflected by the tissue with a reference. In such ways, microscopic details of lesions and tissues can be visualized. This information can be used to identify a lesion as BCC, and to specify the subtype. Therefore, we assume that the use of the OCT might reduce the number of biopsies and the accompanying morbidity. The investigator scans 6mm of skin with the OCT (30 seconds) and decides whether the lesion is a BCC or not.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
The investigator is blinded for the result of the punch biopsy.
Intervention model description
Multi-centre randomised controlled non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed