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Enrolling by Invitation

NCT Number: NCT07347392

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.

Enrolling by Invitation

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Key information

Conditions

Non-Melanoma Skin Cancer (NMSC) Basal Cell Carcinoma of Skin Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of the Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up visit at least two years after treatment

Other

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Other outcomes

  1. Effect of Treatment-Related Factors

    Time frame: At least 2 years after completion of radiotherapy

    Associations betweem outcomes and field size, field location

  2. 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 .

  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DOSCA-2

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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