Basal Cell Carcinoma Clinical Trial
— ROCTIOfficial 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
Verified date | February 2021 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 598 |
Est. completion date | October 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht UMC+ | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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. Review. — View 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. — View Citation
NVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with treatment failure | 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. | 12 months | |
Primary | Cost-effectiveness of OCT | 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). | 12 months | |
Secondary | The proportion of patients with avoided biopsies | What percentage of biopsies can be avoided in patients when using optical coherence tomography compared to regular care. | 12 months | |
Secondary | Diagnostic performance of OCT | 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. | 12 months | |
Secondary | Discrete Choice Experiment to determine patient preferences | Patient preferences will be assessed by designing and conducting a discrete choice experiment. | 2 months | |
Secondary | Quality of life measured with EQ-5D-5L | Quality of life will be evaluated using the 5-level EQ-5D version (EQ-5D-5L) questionnaire. | Baseline, 12 months |
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