(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

(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 - (Cost-)effectiveness of optical coherence tomography (OCT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48208

Enrollment

598

Registered

2018-12-19

Start date

2019-02-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal cell carcinoma skin cancer

Interventions

OCT guided diagnosis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: - Adult patient (>18 years) - Clinical and dermoscopic suspicion of basal cell carcinoma (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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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
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. The main endpoint for the cost-effectiveness analysis is the ICER defined as extra cost per gained QALY.	—

Secondary

Measure	Time frame
Secondary outcomes are: the proportion of patients with avoided biopsies. 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. Patient preferences will be assessed by conducting a discrete choice experiment. Quality of life at baseline and at 12 months follow-up will be evaluated using the EQ-5D-5L questionnaire.	—

Measure

Time frame

Secondary outcomes are: the proportion of patients with avoided biopsies. 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. Patient preferences will be assessed by conducting a discrete choice experiment. Quality of life at baseline and at 12 months follow-up will be evaluated using the EQ-5D-5L questionnaire.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)