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

NCT ID: NCT07347392

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2029-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Melanoma Skin Cancer (NMSC) Basal Cell Carcinoma of Skin Squamous Cell Carcinoma of the Skin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Follow-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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jesper Grau Eriksen, Professor MD PhD

Role: STUDY_CHAIR

Department of Experimential Clinical Oncology, Aarhus University Hospital, Denmark

Anita Gothelf, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark

Pernille Lassen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Copenhagen University Hospital, Herlev, Denmark

Rasmus Kjeldsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Aalborg University Hospital, Denmark

Gulalai Hanan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Vejle Hospital, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus University Hospital

Aarhus N, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20393962 (View on PubMed)

Thomson 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.

Reference Type BACKGROUND
PMID: 33202063 (View on PubMed)

Drucker 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.

Reference Type BACKGROUND
PMID: 30242379 (View on PubMed)

Likhacheva 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.

Reference Type BACKGROUND
PMID: 31831330 (View on PubMed)

Zaorsky 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.

Reference Type BACKGROUND
PMID: 28843727 (View on PubMed)

Schulte 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.

Reference Type BACKGROUND
PMID: 16310060 (View on PubMed)

Cognetta 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.

Reference Type BACKGROUND
PMID: 22818756 (View on PubMed)

Benkhaled 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.

Reference Type BACKGROUND
PMID: 35833108 (View on PubMed)

Braendstrup 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.

Reference Type RESULT
PMID: 40442261 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.cancer.org.au/clinical-guidelines/skin-cancer/keratinocyte-cancer

Cancer Council Australia Keratinoyte Cancer Guidelines Working Party. Clinical Practice Guidelines for Keratinoyte Cancer. 25 Novembe

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DOSCA-2-AUH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RT for Adenocarcinoma/Adenosquamous Carcinoma
NCT07153952 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Curatively Intended Thoracic Reirradiation
NCT06950073 NOT_YET_RECRUITING