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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 704
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with one or more clinically suspicious lesions of BCC for which:
- •The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
- •And/or for which the knowledge of the histological subtype determines the subsequent management.
- •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).
排除标准
- •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.
研究组 & 干预措施
Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device
The interventional procedure involves the management of BCC with an initial diagnosis based on the deepLive™ device. The imaging is performed by placing the probe tip in contact with the patient's skin after applying an immersion oil (paraffin) to the imaging area. The examination lasts only a few minutes and is painless. An integrated dermoscopic targeting system allows the operator to ensure proper positioning of the probe on the lesion and to ensure that the entire lesion has been captured for an accurate diagnosis. The images are displayed in real-time during the examination and directly evaluated by the investigator, who has the option to save images/videos at their discretion. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up, and intermediate evaluations may also be performed with the deepLive™ device depending on the initial management of BCC.
干预措施: diagnosis based on deepLive™ LC-OCT device (Diagnostic Test)
Control Arm: Standard management with an initial diagnosis based on skin biopsy
The control procedure corresponds to standard management of BCC with an initial diagnosis based on skin biopsy (standard management arm). The biopsy will be performed according to the standard practice of each center, using a 2 to 6 mm punch or shave biopsy, with prior injection of a local anesthetic. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up.
干预措施: diagnosis based on skin biopsy (Diagnostic Test)
结局指标
主要结局
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.
时间窗: from enrollment to the 1 year follow up
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.
次要结局
- Estimate the actual cost of conducting the diagnosis with LC-OCT technology.(from enrollment to the 1 year follow up)
- Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management.(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.(from enrollment to the 1 year follow up)
- Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm(from enrollment to the 1 year follow up)
- Compare healthcare consumption between the two groups at 1 year.(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.(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.(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.(from enrollment to the 1 year follow up)