The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark. (DOSCA-2)

January 8, 2026 updated by: University of Aarhus

The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years or older with head and neck non-melanoma skin cancer (basal cell carcinoma or cutaneous squamous cell carcinoma) who received primary radiotherapy between 2020 and 2024 at five Danish oncology centres. Participants will be invited via the national digital mailbox (e-Boks) to attend a hospital follow-up visit at the centre where they received radiotherapy, at least two years after completion of treatment. The study represents a real-world national cohort within the Danish public health-care system.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic outcome
Time Frame: 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.
At least 2 years after completion of primary radiotherapy for NMSC
Local recurrence
Time Frame: At least 2 years after completion of primary radiotherapy for NMSC
Identified through the Danish Pathology Registry and follow-up visit
At least 2 years after completion of primary radiotherapy for NMSC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Tumour Histology
Time Frame: 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.
At least 2 years after completion of radiotherapy
Comparison between Short-Course and Long-Course Radiotherapy Regimens
Time Frame: At least 2 years after completion of radiotherapy
Differences in risk of recurrence between the treatment regimens will be analyzed.
At least 2 years after completion of radiotherapy
Effect of Tumour Histology
Time Frame: At least 2 years after completion of radiotherapy
Differences in cosmetic outcome between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed
At least 2 years after completion of radiotherapy
Comparison between Short-Course and Long-Course Radiotherapy Regimens
Time Frame: At least 2 years after completion of radiotherapy.
Differences in cosmetic outcome between the treatment regimens will be analyzed.
At least 2 years after completion of radiotherapy.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Treatment-Related Factors
Time Frame: At least 2 years after completion of radiotherapy
Associations betweem outcomes and field size, field location
At least 2 years after completion of radiotherapy
Effect of Tumour Related Factors
Time Frame: At least 2 years after completion of radiotherapy
Associations between outcomes and tumour related factors such as location and TNM stage .
At least 2 years after completion of radiotherapy
Effect of Patient-Related Factors
Time Frame: At least 2 years after completion of radiotherapy
Associations between outcomes and patients factors such as age, sex, smoking status, performance status, previous NMSC
At least 2 years after completion of radiotherapy
Effect of Radiotherapy Modality
Time Frame: 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)
At least 2 years after completion of primary radiotherapy for NMSC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev
Danish Cancer Society
Vejle Hospital
Aalborg University Hospital

Investigators

  • Study Chair: Jesper Grau Eriksen, Professor MD PhD, Department of Experimential Clinical Oncology, Aarhus University Hospital, Denmark
  • Principal Investigator: Anita Gothelf, MD PhD, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
  • Principal Investigator: Pernille Lassen, MD PhD, Department of Oncology, Copenhagen University Hospital, Herlev, Denmark
  • Principal Investigator: Rasmus Kjeldsen, MD, Department of Oncology, Aalborg University Hospital, Denmark
  • Principal Investigator: Gulalai Hanan, MD, Department of Oncology, Vejle Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOSCA-2-AUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available due to Danish data protection regulations. Aggregate results will be published in peer-reviewed journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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