The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- Cosmetic outcome
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of radiotherapy for people who were treated for non-melanoma skin cancer (NMSC) in the head and neck area. The study focuses on adults who finished radiotherapy at least two years ago.
The main questions we aim to answer are:
How satisfied are participants with the cosmetic result of their treatment?
What skin changes do healthcare professionals observe at the treated area?
How many participants have experienced a recurrence or developed a new skin cancer, since treatment?
Participants will be invited to:
Attend one extra hospital visit at least two years after they finished radiotherapy
Answer a short questionnaire about their cosmetic satisfaction
Have their skin examined, including photos and dermatoscopy
The results may help improve future treatment guidelines for people with non-melanoma skin cancer.professional, and any local recurrences will be identified through national health registries.
This nationwide study (DOSCA-2) will provide real-world data to help guide future treatment recommendations for NMSC.
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
- 否
入选标准
- •Adults aged 18 years or older
- •Received primary radiotherapy for malignant non-melanoma skin cancer (basal cell carcinoma or cutaneous squamous cell carcinoma) of the head and neck region between 2020 and 2024
- •Able to understand and communicate in written and spoken Danish or English
排除标准
- •Individuals who are incapable of giving informed consent
结局指标
主要结局
Cosmetic outcome
时间窗: At least 2 years after completion of primary radiotherapy for NMSC
The primary outcome is cosmetic outcome, assessed by both the patient and a health professional using the LENT-SOMA criteria.
Local recurrence
时间窗: At least 2 years after completion of primary radiotherapy for NMSC
Identified through the Danish Pathology Registry and follow-up visit
次要结局
- Effect of Tumour Histology(At least 2 years after completion of radiotherapy)
- Comparison between Short-Course and Long-Course Radiotherapy Regimens(At least 2 years after completion of radiotherapy)
- Comparison between Short-Course and Long-Course Radiotherapy Regimens(At least 2 years after completion of radiotherapy.)