Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT05377957
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013637', 'term': 'Tape Recording'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uveal melanoma-related quality of life', 'timeFrame': '5 years', 'description': 'EORTC QLQ-OPT30'}, {'measure': 'Health-related quality of life', 'timeFrame': '5 years', 'description': 'EORTC QLQ-C30'}, {'measure': 'General quality of life', 'timeFrame': '5 years', 'description': 'EQ-5D-5L'}, {'measure': 'Impact of the diagnosis and treatment of uveal melanoma on mental health', 'timeFrame': '2 years', 'description': 'Impact of events scale'}], 'secondaryOutcomes': [{'measure': 'Patient preferences for outcomes of proton therapy and enucleation', 'timeFrame': 'Cross-sectional at baseline', 'description': 'Discrete choice experiment'}, {'measure': 'Shared decision-making', 'timeFrame': '1 year', 'description': 'Audiotape, iSHARE, satisfaction with decision scale, decision regret scale'}, {'measure': 'Impact of side-effects of treatment for uveal melanoma', 'timeFrame': '3 years', 'description': 'Questionnaire specifically developed for uveal melanoma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uveal Melanoma', 'Quality of Life', 'Shared decision-making', 'Patient preferences', 'Brachytherapy', 'Proton therapy', 'Enucleation'], 'conditions': ['Uveal Melanoma']}, 'descriptionModule': {'briefSummary': 'PROQEM is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.', 'detailedDescription': 'PROQEM is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. A comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning.\n\nIn addition, the PROQEM has a substudy called the PROQEM-pco (Preferences, Choices and Outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. They are invited to participate in research on patient preferences and shared decision-making. The consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with uveal melanoma who will be treated with brachytherapy, proton therapy or enucleation with curative intent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical or pathological diagnosis of a melanoma of the choroid or ciliary body\n* No signs of metastasis after staging procedures with at least an X-thorax, blood test and an ultrasound of the liver\n* Treatment by brachytherapy, proton therapy or enucleation\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05377957', 'acronym': 'PROQEM', 'briefTitle': 'Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients', 'orgStudyIdInfo': {'id': 'PROQEM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brachytherapy', 'description': 'Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy', 'interventionNames': ['Other: Quality of life questionnaires']}, {'label': 'Proton therapy', 'description': 'Uveal melanoma patients treated with proton therapy', 'interventionNames': ['Other: Quality of life questionnaires', 'Other: Discrete choice experiment', 'Other: Shared decision-making analysis', 'Other: Impact of side-effects analysis']}, {'label': 'Enucleation', 'description': 'Uveal melanoma patients treated with enucleation', 'interventionNames': ['Other: Quality of life questionnaires', 'Other: Discrete choice experiment', 'Other: Shared decision-making analysis', 'Other: Impact of side-effects analysis']}], 'interventions': [{'name': 'Quality of life questionnaires', 'type': 'OTHER', 'otherNames': ['EORTC-QLQ-C30', 'EORTC-QLQ-OPT30', 'EQ-5D-5L', 'Impact of events scale'], 'description': 'Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis', 'armGroupLabels': ['Brachytherapy', 'Enucleation', 'Proton therapy']}, {'name': 'Discrete choice experiment', 'type': 'OTHER', 'otherNames': ['DCE'], 'description': 'Assessment of patient preferences for outcomes of proton therapy and enucleation', 'armGroupLabels': ['Enucleation', 'Proton therapy']}, {'name': 'Shared decision-making analysis', 'type': 'OTHER', 'otherNames': ['Audiotape', 'iSHARE', 'Satisfaction with decision scale', 'Decision regret scale'], 'description': 'Assessment of shared decision-making from the perspective of the patient (by questionnaire), physician (by questionnaire) and a neutral observer (by audiotape), combined with patient-reported satisfaction and regret of the treatment decision (by questionnaire)', 'armGroupLabels': ['Enucleation', 'Proton therapy']}, {'name': 'Impact of side-effects analysis', 'type': 'OTHER', 'description': 'Assessment of the impact of side-effects by questionnaire', 'armGroupLabels': ['Enucleation', 'Proton therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333ZA', 'city': 'Leiden', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nanda Horeweg, MD PhD', 'role': 'CONTACT', 'email': 'n.horeweg@lumc.nl', 'phone': '+31725165539'}, {'name': 'Coen RN Rasch, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gré PM Luyten, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marina Marinkovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Arwen H Pieterse, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'centralContacts': [{'name': 'Nanda Horeweg, MD PhD', 'role': 'CONTACT', 'email': 'n.horeweg@lumc.nl', 'phone': '+31725165539'}], 'overallOfficials': [{'name': 'Nanda Horeweg, Md PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After completion of the analysis and publication of the secondary endpoints by the PROQEM research group; until 15 years after the last publication.', 'ipdSharing': 'YES', 'description': 'The PROQEM study adheres to the FAIR principles of data stewardship. Due to privacy regulations the data of the PROQEM study will not be made publicly accessible, but can be made available upon request.', 'accessCriteria': 'Data available upon reasonable request. A research proposal should be send to the chief investigator. Subject to ethical approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher, department of radiation oncology', 'investigatorFullName': 'Nanda Horeweg', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}