Basal Cell Carcinoma of Skin, Non-Melanoma Skin Cancer (NMSC), Squamous Cell Carcinoma of the Skin
Conditions
Brief summary
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.
Interventions
OTHERFollow-up visit at least two years after treatment
In Denmark, people treated with primary radiotherapy for NMSC are not routinely offered a hospital follow-up visit to evaluate cosmetic results or recurrence. In this study, patients who received radiotherapy between 2020 and 2024 at five Danish cancer centers will be invited for a clinical examination at least two years after treatment. Cosmetic outcome will be rated by both the patient and a health professional, and any local recurrences will be identified through national health registries.
Sponsors
Aarhus University Hospital
Aalborg University Hospital
Vejle Hospital
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Danish Cancer Society
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Individuals who are incapable of giving informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic outcome | 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 | At least 2 years after completion of primary radiotherapy for NMSC | Identified through the Danish Pathology Registry and follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Tumour Histology | At least 2 years after completion of radiotherapy | Differences in risk of recurrence between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed. |
| Comparison between Short-Course and Long-Course Radiotherapy Regimens | At least 2 years after completion of radiotherapy | Differences in risk of recurrence between the treatment regimens will be analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Treatment-Related Factors | At least 2 years after completion of radiotherapy | Associations betweem outcomes and field size, field location |
| Effect of Tumour Related Factors | At least 2 years after completion of radiotherapy | Associations between outcomes and tumour related factors such as location and TNM stage . |
| Effect of Patient-Related Factors | At least 2 years after completion of radiotherapy | Associations between outcomes and patients factors such as age, sex, smoking status, performance status, previous NMSC |
| Effect of Radiotherapy Modality | At least 2 years after completion of primary radiotherapy for NMSC | Associations on recurrence and cosmetic outcome depending on radiotherapy modality (kilovoltage (kV), electrons, photons) |
Countries
Denmark
Outcome results
None listed