Clinical trial NCT06271603: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas
Official title: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas (ECOBASO)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma of the Skin
Keywords: basal cell carcinoma diagnosis
LC-OCT
Lead sponsor: Damae Medical
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \&#34;equivocal\&#34; 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 \&#34;optical\&#34; 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.

Eligibility criteria: Inclusion Criteria:

Patient with one or more clinically suspicious lesions of BCC for which:

1. The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
2. And/or for which the knowledge of the histological subtype determines the subsequent management.
3. And/or for which diagnostic biopsy is necessary in the standard practice to confirm the clinical diagnosis (peri-orificial facial lesions, any lesion that may require complex surgical reconstruction).

Exclusion Criteria:

* The lesion is suspected to be a recurrent BCC.
* The suspicious lesion has been previously treated by other surgical or non-surgical methods (cryotherapy, topical treatment, PDT, etc.).
* Lesions within 3 cm of the eye.
* Presence of cutaneous comorbidities that could interfere with a proper evaluation of the studied lesion according to the investigator.

Primary outcomes:
measure: 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.
timeFrame: from enrollment to the 1 year follow up
measure: 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.
timeFrame: from enrollment to the 1 year follow up
measure: 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.
timeFrame: from enrollment to the 1 year follow up
Secondary outcomes:
measure: 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.
timeFrame: from enrollment to the 1 year follow up
measure: Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm.
timeFrame: from enrollment to the 1 year follow up
measure: Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm.
timeFrame: from enrollment to the 1 year follow up
measure: 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.
timeFrame: from enrollment to the 1 year follow up
measure: Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm
timeFrame: from enrollment to the 1 year follow up
measure: Estimate the actual cost of conducting the diagnosis with LC-OCT technology.
timeFrame: from enrollment to the 1 year follow up
measure: Compare healthcare consumption between the two groups at 1 year.
timeFrame: from enrollment to the 1 year follow up
measure: Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management.
timeFrame: from enrollment to the 1 year follow up
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
Study officials:
References: