Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT05976061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2023-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High- and Low-risk Actinic Keratosis Referrals to Secondary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3379}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.', 'timeFrame': '2018 compared to 2019 (2 years)', 'description': "The change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients referred by the general practitioner to the dermatologist. The definition of low-risk actinic keratosis patients was based on the General Practitioners guidelines 'Suspicious skin lesions' (published in 2017). Patients were defined as low-risk when they were not immunocompromised, did not have a cutaneous malignancy in their medical history, did not have previous treatment or if they did not have extensive lesions."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['General Practitioners guidelines', 'actinic keratosis', 'general physician', 'dermatology', 'low-risk patients', 'referrals'], 'conditions': ['Actinic Keratoses']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://richtlijnen.nhg.org/standaarden/verdachte-huidafwijkingen', 'label': "the Dutch College of General Practitioners guidelines 'Suspicious Skin lesions'. \\[updated 2020\\]."}]}, 'descriptionModule': {'briefSummary': "This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.", 'detailedDescription': 'In the Dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. Both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner.\n\nThis retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data from patients are collected retrospectively using the Electronic health records. Patients were selected based on the diagnosis-treatment-combination (DTC) 17 (premalignant lesion) and DTC 14 (cutaneous malignancy) that was registered from January 2018 to December 2019 by the dermatologist.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of 18 years and older\n* referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist\n* treated at MaastrichtUMC+ or TergooiHospital\n\nExclusion Criteria:\n\n* different diagnosis than actinic keratosis\n* referred by a different specialist than the general practitioner\n* referred with multiple problems\n* referred for a second opinion\n* if the patients was treated as different diagnosis than actinic keratosis by general practitioner'}, 'identificationModule': {'nctId': 'NCT05976061', 'briefTitle': 'High- and Low-risk Actinic Keratosis Referrals to Secondary Care', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.', 'orgStudyIdInfo': {'id': '2020-2432'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low risk patients', 'description': 'Low risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.'}, {'label': 'High risk patients', 'description': 'High risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Ellen Oyen', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Klara Mosterd, prof.dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC+'}, {'name': 'Maud Jansen, dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC+'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tergooi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}