Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:07 AM
Study NCT ID:
NCT07347392
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-16
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000359', 'term': 'Aftercare'}], 'ancestors': [{'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2900}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of Treatment-Related Factors', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Associations betweem outcomes and field size, field location'}, {'measure': 'Effect of Tumour Related Factors', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Associations between outcomes and tumour related factors such as location and TNM stage .'}, {'measure': 'Effect of Patient-Related Factors', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Associations between outcomes and patients factors such as age, sex, smoking status, performance status, previous NMSC'}, {'measure': 'Effect of Radiotherapy Modality', 'timeFrame': 'At least 2 years after completion of primary radiotherapy for NMSC', 'description': 'Associations on recurrence and cosmetic outcome depending on radiotherapy modality (kilovoltage (kV), electrons, photons)'}], 'primaryOutcomes': [{'measure': 'Cosmetic outcome', 'timeFrame': 'At least 2 years after completion of primary radiotherapy for NMSC', 'description': 'The primary outcome is cosmetic outcome, assessed by both the patient and a health professional using the LENT-SOMA criteria.'}, {'measure': 'Local recurrence', 'timeFrame': 'At least 2 years after completion of primary radiotherapy for NMSC', 'description': 'Identified through the Danish Pathology Registry and follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Effect of Tumour Histology', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Differences in risk of recurrence between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed.'}, {'measure': 'Comparison between Short-Course and Long-Course Radiotherapy Regimens', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Differences in risk of recurrence between the treatment regimens will be analyzed.'}, {'measure': 'Effect of Tumour Histology', 'timeFrame': 'At least 2 years after completion of radiotherapy', 'description': 'Differences in cosmetic outcome between basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) will be analyzed'}, {'measure': 'Comparison between Short-Course and Long-Course Radiotherapy Regimens', 'timeFrame': 'At least 2 years after completion of radiotherapy.', 'description': 'Differences in cosmetic outcome between the treatment regimens will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Melanoma Skin Cancer (NMSC)', 'Basal Cell Carcinoma of Skin', 'Squamous Cell Carcinoma of the Skin']}, 'referencesModule': {'references': [{'pmid': '20393962', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33202063', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30242379', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31831330', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28843727', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16310060', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22818756', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35833108', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40442261', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.org.au/clinical-guidelines/skin-cancer/keratinocyte-cancer', 'label': 'Cancer Council Australia Keratinoyte Cancer Guidelines Working Party. Clinical Practice Guidelines for Keratinoyte Cancer. 25 Novembe'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions we aim to answer are:\n\nHow satisfied are participants with the cosmetic result of their treatment?\n\nWhat skin changes do healthcare professionals observe at the treated area?\n\nHow many participants have experienced a recurrence or developed a new skin cancer, since treatment?\n\nParticipants will be invited to:\n\nAttend one extra hospital visit at least two years after they finished radiotherapy\n\nAnswer a short questionnaire about their cosmetic satisfaction\n\nHave their skin examined, including photos and dermatoscopy\n\nThe 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.\n\nThis nationwide study (DOSCA-2) will provide real-world data to help guide future treatment recommendations for NMSC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* 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\n* Able to understand and communicate in written and spoken Danish or English\n\nExclusion Criteria:\n\n* Individuals who are incapable of giving informed consent'}, 'identificationModule': {'nctId': 'NCT07347392', 'acronym': 'DOSCA-2', 'briefTitle': 'The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark', 'orgStudyIdInfo': {'id': 'DOSCA-2-AUH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Follow-up visit at least two years after treatment', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'overallOfficials': [{'name': 'Jesper Grau Eriksen, Professor MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Experimential Clinical Oncology, Aarhus University Hospital, Denmark'}, {'name': 'Anita Gothelf, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark'}, {'name': 'Pernille Lassen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Copenhagen University Hospital, Herlev, Denmark'}, {'name': 'Rasmus Kjeldsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Aalborg University Hospital, Denmark'}, {'name': 'Gulalai Hanan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Vejle Hospital, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be publicly available due to Danish data protection regulations. Aggregate results will be published in peer-reviewed journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}