Non-Melanoma Skin Cancer (NMSC)DOSCA-2NCT07347392
The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark.
An observational study of Non-Melanoma Skin Cancer (NMSC) and Basal Cell Carcinoma of Skin, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Melanoma Skin Cancer (NMSC), Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- What is being tested?
- Follow-up visit at least two years after treatment
- How many people
- 2,900 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2025to 1 Sep 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Individuals who are incapable of giving informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
- Conditions
- Non-Melanoma Skin Cancer (NMSC), Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Being tested
- Follow-up visit at least two years after treatment
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up visit at least two years after treatmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome
The primary outcome is cosmetic outcome, assessed by both the patient and a health professional using the LENT-SOMA criteria.
Measured: At least 2 years after completion of primary radiotherapy for NMSC
Local recurrence
Identified through the Danish Pathology Registry and follow-up visit
Measured: At least 2 years after completion of primary radiotherapy for NMSC
Secondary outcomes (4)
Effect of Tumour Histology
Differences in risk of recurrence between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed.
Measured: At least 2 years after completion of radiotherapy
Comparison between Short-Course and Long-Course Radiotherapy Regimens
Differences in risk of recurrence between the treatment regimens will be analyzed.
Measured: At least 2 years after completion of radiotherapy
Effect of Tumour Histology
Differences in cosmetic outcome between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed
Measured: At least 2 years after completion of radiotherapy
Comparison between Short-Course and Long-Course Radiotherapy Regimens
Differences in cosmetic outcome between the treatment regimens will be analyzed.
Measured: At least 2 years after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Dec 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Non-Melanoma Skin Cancer (NMSC)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,900 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Vejle Hospital, Copenhagen University Hospital, Rigshospitalet, Copenhagen University Hospital at Herlev, Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Jesper Grau Eriksen, Professor MD PhD, Study chair, Department of Experimential Clinical Oncology, Aarhus University Hospital, DenmarkAnita Gothelf, MD PhD, Principal investigator, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, DenmarkPernille Lassen, MD PhD, Principal investigator, Department of Oncology, Copenhagen University Hospital, Herlev, DenmarkRasmus Kjeldsen, MD, Principal investigator, Department of Oncology, Aalborg University Hospital, DenmarkGulalai Hanan, MD, Principal investigator, Department of Oncology, Vejle Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347392
- Sponsor's protocol ID
- DOSCA-2-AUH
- Acronym
- DOSCA-2
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to Danish data protection regulations. Aggregate results will be published in peer-reviewed journals.
Publications
Lansbury L, Leonardi-Bee J, Perkins W, Goodacre T, Tweed JA, Bath-Hextall FJ. Interventions for non-metastatic squamous cell carcinoma of the skin. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD007869. doi: 10.1002/14651858.CD007869.pub2.
PubMed 20393962Thomson J, Hogan S, Leonardi-Bee J, Williams HC, Bath-Hextall FJ. Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD003412. doi: 10.1002/14651858.CD003412.pub3.
PubMed 33202063Drucker AM, Adam GP, Rofeberg V, Gazula A, Smith B, Moustafa F, Weinstock MA, Trikalinos TA. Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2018 Oct 2;169(7):456-466. doi: 10.7326/M18-0678. Epub 2018 Sep 18.
PubMed 30242379Likhacheva A, Awan M, Barker CA, Bhatnagar A, Bradfield L, Brady MS, Buzurovic I, Geiger JL, Parvathaneni U, Zaky S, Devlin PM. Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. Pract Radiat Oncol. 2020 Jan-Feb;10(1):8-20. doi: 10.1016/j.prro.2019.10.014. Epub 2019 Dec 9.
PubMed 31831330Zaorsky NG, Lee CT, Zhang E, Keith SW, Galloway TJ. Hypofractionated radiation therapy for basal and squamous cell skin cancer: A meta-analysis. Radiother Oncol. 2017 Oct;125(1):13-20. doi: 10.1016/j.radonc.2017.08.011. Epub 2017 Aug 23.
PubMed 28843727Schulte KW, Lippold A, Auras C, Bramkamp G, Breitkopf C, Elsmann HJ, Habenicht EM, Jasnoch V, Muller-Pannes H, Rupprecht R, Suter L. Soft x-ray therapy for cutaneous basal cell and squamous cell carcinomas. J Am Acad Dermatol. 2005 Dec;53(6):993-1001. doi: 10.1016/j.jaad.2005.07.045.
PubMed 16310060Cognetta AB, Howard BM, Heaton HP, Stoddard ER, Hong HG, Green WH. Superficial x-ray in the treatment of basal and squamous cell carcinomas: a viable option in select patients. J Am Acad Dermatol. 2012 Dec;67(6):1235-41. doi: 10.1016/j.jaad.2012.06.001. Epub 2012 Jul 19.
PubMed 22818756Benkhaled S, Van Gestel D, Gomes da Silveira Cauduro C, Palumbo S, Del Marmol V, Desmet A. The State of the Art of Radiotherapy for Non-melanoma Skin Cancer: A Review of the Literature. Front Med (Lausanne). 2022 Jun 27;9:913269. doi: 10.3389/fmed.2022.913269. eCollection 2022.
PubMed 35833108Braendstrup ON, Lassen P, Gothelf AB, De Blanck SR, Friborg J, Lonkvist CK, Nielsen AL, Primdahl H, Hanan G, Toure M, Andersen M, Nowicka-Matus K, Kjeldsen R, Eriksen JG. Initial cosmetic outcome six months after kilovoltage therapy of facial basal cell carcinoma: A Danish national prospective study of 932 patients. Sci Rep. 2025 May 29;15(1):18790. doi: 10.1038/s41598-025-03566-8.
PubMed 40442261
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark
- ClinicalTrials.gov ID
- NCT07347392
- Acronym / sponsor ID
- DOSCA-2 / DOSCA-2-AUH
- Conditions
- Non-Melanoma Skin Cancer (NMSC), Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Vejle Hospital, Copenhagen University Hospital, Rigshospitalet, Copenhagen University Hospital at Herlev, Danish Cancer Society
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals who are incapable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up visit at least two years after treatmentIn 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. | Other | – |
Primary outcome
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.
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
4 secondary outcomes
Effect of Tumour Histology
Time frame: 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
Effect of Tumour Histology
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 20393962Lansbury L, Leonardi-Bee J, Perkins W, Goodacre T, Tweed JA, Bath-Hextall FJ. Interventions for non-metastatic squamous cell carcinoma of the skin. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD007869. doi: 10.1002/14651858.CD007869.pub2.
- Background: PubMed 33202063Thomson J, Hogan S, Leonardi-Bee J, Williams HC, Bath-Hextall FJ. Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD003412. doi: 10.1002/14651858.CD003412.pub3.
- Background: PubMed 30242379Drucker AM, Adam GP, Rofeberg V, Gazula A, Smith B, Moustafa F, Weinstock MA, Trikalinos TA. Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2018 Oct 2;169(7):456-466. doi: 10.7326/M18-0678. Epub 2018 Sep 18.
- Background: PubMed 31831330Likhacheva A, Awan M, Barker CA, Bhatnagar A, Bradfield L, Brady MS, Buzurovic I, Geiger JL, Parvathaneni U, Zaky S, Devlin PM. Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. Pract Radiat Oncol. 2020 Jan-Feb;10(1):8-20. doi: 10.1016/j.prro.2019.10.014. Epub 2019 Dec 9.
- Background: PubMed 28843727Zaorsky NG, Lee CT, Zhang E, Keith SW, Galloway TJ. Hypofractionated radiation therapy for basal and squamous cell skin cancer: A meta-analysis. Radiother Oncol. 2017 Oct;125(1):13-20. doi: 10.1016/j.radonc.2017.08.011. Epub 2017 Aug 23.
- Background: PubMed 16310060Schulte KW, Lippold A, Auras C, Bramkamp G, Breitkopf C, Elsmann HJ, Habenicht EM, Jasnoch V, Muller-Pannes H, Rupprecht R, Suter L. Soft x-ray therapy for cutaneous basal cell and squamous cell carcinomas. J Am Acad Dermatol. 2005 Dec;53(6):993-1001. doi: 10.1016/j.jaad.2005.07.045.
- Background: PubMed 22818756Cognetta AB, Howard BM, Heaton HP, Stoddard ER, Hong HG, Green WH. Superficial x-ray in the treatment of basal and squamous cell carcinomas: a viable option in select patients. J Am Acad Dermatol. 2012 Dec;67(6):1235-41. doi: 10.1016/j.jaad.2012.06.001. Epub 2012 Jul 19.
- Background: PubMed 35833108Benkhaled S, Van Gestel D, Gomes da Silveira Cauduro C, Palumbo S, Del Marmol V, Desmet A. The State of the Art of Radiotherapy for Non-melanoma Skin Cancer: A Review of the Literature. Front Med (Lausanne). 2022 Jun 27;9:913269. doi: 10.3389/fmed.2022.913269. eCollection 2022.
- Results publication: PubMed 40442261Braendstrup ON, Lassen P, Gothelf AB, De Blanck SR, Friborg J, Lonkvist CK, Nielsen AL, Primdahl H, Hanan G, Toure M, Andersen M, Nowicka-Matus K, Kjeldsen R, Eriksen JG. Initial cosmetic outcome six months after kilovoltage therapy of facial basal cell carcinoma: A Danish national prospective study of 932 patients. Sci Rep. 2025 May 29;15(1):18790. doi: 10.1038/s41598-025-03566-8.
- Cancer Council Australia Keratinoyte Cancer Guidelines Working Party. Clinical Practice Guidelines for Keratinoyte Cancer. 25 NovembeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to Danish data protection regulations. Aggregate results will be published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper Grau Eriksen, Professor MD PhD study chair
Department of Experimential Clinical Oncology, Aarhus University Hospital, Denmark
Anita Gothelf, MD PhD principal investigator
Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
Pernille Lassen, MD PhD principal investigator
Department of Oncology, Copenhagen University Hospital, Herlev, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Melanoma Skin Cancer (NMSC) and Basal Cell Carcinoma of Skin, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic outcome (time frame: At least 2 years after completion of primary radiotherapy for NMSC). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347392, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.