This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.
Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \"equivocal\" lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for \"optical\" biopsies, which appear as an attractive alternative to traditional biopsies. The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
704
Management of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT technology.
Control Arm: Standard management with an initial diagnosis based on skin biopsy
Hôpital Ambroise Paré
Boulogne-Billancourt, France
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. The clinical non-inferiority will be assessed by the proportion of success which is defined as the absence of residual or recurrent cancerous or precancerous lesions after 1 year of primary BCC through diagnosis with LC-OCT, as compared to traditional management.
Time frame: from enrollment to the 1 year follow up
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Organizational effectiveness will be evaluated by measuring the total time spent by dermatologists and pathologists (in hours) for managing primary BCC through diagnosis with LC-OCT, as compared to traditional management.
Time frame: from enrollment to the 1 year follow up
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Economic superiority will be assessed by comparing the total cost of management (€) of primary BCC through diagnosis with LC-OCT to traditional management.
Time frame: from enrollment to the 1 year follow up
Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm.
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Quality of life will be assessed using the EQ-5D-5L questionnaire
Time frame: from enrollment to the 1 year follow up
Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm.
Anxiety will be assessed using a visual analog scale (score 0 - 10)
Time frame: from enrollment to the 1 year follow up
Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm.
Patient satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.
Time frame: from enrollment to the 1 year follow up
Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm.
Performance will be evaluated based on the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and accuracy of LC-OCT for the diagnosis and subtyping of BCC in all patients operated on or biopsied in the LC-OCT arm, using histological diagnosis as the gold standard.
Time frame: from enrollment to the 1 year follow up
Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm
Physician satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.
Time frame: from enrollment to the 1 year follow up
Estimate the actual cost of conducting the diagnosis with LC-OCT technology.
Actual cost (€) of conducting the diagnosis with deepLive™ measured using micro-costing methodology
Time frame: from enrollment to the 1 year follow up
Compare healthcare consumption between the two groups at 1 year.
Typology of healthcare consumption at 1 year in each group to identify differences between the two groups in terms of: consultations, treatments, hospitalizations, medical procedures, laboratory tests, imaging, etc.
Time frame: from enrollment to the 1 year follow up
Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management.
The descriptive cost-consequence analysis will analyze the difference in patient management costs at 1 year in relation to the impacts of deepLive™ on other clinical and organizational criteria.
Time frame: from enrollment to the 1 year follow up