Real-world Evaluation of (Non-invasive) Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Effectiveness of imiquimod versus surgical excision
研究概览
简要总结
Basal cell carcinoma (BCC) is the most prevalent form of cancer among the Caucasian population. There are several subtypes of BCC with different clinical characteristics and treatment strategies. Superficial and nodular BCCs are low-risk BCC subtypes. The diagnosis and subtype of BCC can be confirmed by means of punch biopsy, but non-invasive diagnosis by means of Optical Coherence Tomography (OCT) is proven to be a non-inferior alternative diagnostic instrument. Besides, non-invasive topical treatment is recommended as valuable treatment alternative to surgical excision for low-risk BCC.
Since non-invasive diagnosis and treatment for low-risk BCC is being implemented into daily practice, we want to evaluate the real-world effectiveness of different invasive and non-invasive diagnostic and treatment strategies in the management of low-risk BCC. This real-world evidence will enhance our understanding of these management strategies for low-risk BCC in daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years old
- •Diagnosis of low-risk BCC based on CDE with OCT confirmation or with histopathological verification in case OCT diagnosis is doubtful.
- •Tumors meeting the criteria for low-risk BCC
- •Patient is able to understand the instruction regarding the study participation and application of IMQ treatment
排除标准
- •Tumor location in the H-zone of the face or hairy scalp, anogenital area
- •Diagnosis of recurrent BCC or previous skin cancer within 2cm of the treatment area
- •Strong suspicion/diagnosis of high-risk BCC subtype or other skin condition on OCT or punch biopsy
- •Women who are pregnant or breastfeeding
- •Previous allergy or intolerance to IMQ
- •No concurrent use any other systemic chemopreventive or immunosuppressive medication during the treatment period, 30 days before start and 3 months after the end of treatment
- •Limited understanding of the Dutch language and not being able to give informed consent
结局指标
主要结局
Effectiveness of imiquimod versus surgical excision
时间窗: 1 year post-treatment
Treatment success, expressed as the proportion of tumor free patients
次要结局
- Cost-effectiveness analysis(1 year post-treatment)
- Adverse effects(During imiquimod treatment, reported by the patient)
- Mean treatment compliance for patients in the imiquimod group(During treatment, reported by the patient in a treatment checklist)
- Cosmetic outcome(1 year post-treatment)
- Patient treatment satisfaction(1 year post-treatment)