Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:38 PM
Study NCT ID:
NCT07465133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer - Phase III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': 'Last week or last four weeks', 'description': 'Questionnaire for the quality of life of ovarian cancer patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'EORTC', 'Quality of Life', 'EORTC Quality of life group'], 'conditions': ['Ovarian Cancer', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to pre-test the EORTC QLQ-OV39 to identify and resolve potential problems in its administration and to identify missing/redundant items. A preliminary evaluation of the measurement properties of the module will be carried out.\n\nThe study includes patients with evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV) above the age of 18 years.\n\nThe main aims are:\n\n1. To conduct Phase 3a and 3b pre-testing of the preliminary EORTC-QLQ-OV39 Questionnaire to identify and resolve potential problems in its administration and to identify missing/redundant items according to the updated EORTC QLG Guidelines for Module Development, 5th Edition 2021.(16)\n2. a preliminary assessment of the psychometric properties of the module\n\nParticipants will \\[describe the main tasks participants will be asked to, complete the OV39, C30 and debriefing interviews, as well as questions about their demographics and clinical data.', 'detailedDescription': 'Follows.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ovarian cancer patients from collaborating centers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Evidence of localized (FIGO I-II) or advanced ovarian cancer (FIGO II-IV)\n2. Must be able and willing to complete the questionnaires.\n3. Must be able to understand and speak the language in which the patient will complete the questionnaire.\n4. Age \\> 18 years\n\nExclusion Criteria:\n\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07465133', 'acronym': 'EORTC QOL-OV39', 'briefTitle': 'An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer - Phase III', 'organization': {'class': 'OTHER', 'fullName': 'Helios University Hospital Wuppertal'}, 'officialTitle': 'An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer - Phase III', 'orgStudyIdInfo': {'id': 'OV28 Phase III'}}, 'contactsLocationsModule': {'locations': [{'zip': '42283', 'city': 'Wuppertal', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'contacts': [{'name': 'Vesna Bjelic-Radisic, Prof', 'role': 'CONTACT', 'email': 'vesna.bjelic-radisic@helios-gesundheit.de', 'phone': '+492028961411'}, {'name': 'Jennifer C. Steinmetz', 'role': 'CONTACT', 'email': 'jennifer.steinmetz2@helios-gesundheit.de', 'phone': '+49 202 896 1478'}], 'facility': 'Helios University Clinic Wuppertal, University Witten/Herdecke', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are not publicly available due to privacy restrictions and ethical considerations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios University Hospital Wuppertal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Vesna Bjelic-Radisic, Gynaecologist, Director of the Breast Center', 'investigatorFullName': 'Vesna Bjelic-Radisic', 'investigatorAffiliation': 'Helios University Hospital Wuppertal'}}}}