Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03515993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2018-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up in Gynecological Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '15 months after first patient inclusion', 'description': 'It will be evaluated using self-administered EORTC QLQ-C30 questionnaire'}, {'measure': 'Health-related quality of life', 'timeFrame': '15 months after first patient inclusion', 'description': 'It will be evaluated using self-administered questions on anxiety (from the EORTC quality of life item library)'}, {'measure': 'Health-related quality of life', 'timeFrame': '15 months after first patient inclusion', 'description': 'It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire'}, {'measure': 'Health-related quality of life', 'timeFrame': '15 months after first patient inclusion', 'description': 'It will be evaluated using self-administered EORTC Sexual Health Questionnaire'}, {'measure': 'Health-related quality of life', 'timeFrame': '15 months after first patient inclusion', 'description': 'It will be evaluated using self-administered Distress Thermometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long-term survival', 'gynecologic cancer', 'quality of life'], 'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment', 'detailedDescription': 'The objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer.\n\n1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.\n\nInstitutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.\n\nDescriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva).\n* FIGO stage I-IV before completion of primary therapy.\n* Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).\n* At least 6 months but no more than 5 years since completion of primary treatment.\n* Performance status 0, 1 or 2 (WHO scale).\n* Age ≥ 18 years.\n* Ability to understand and fill out questionnaires.\n* Written informed consent according to ICH/GCP, and national/local regulations.\n\nExclusion Criteria:\n\n* Other cancer diagnosis in the past 5 years.\n* Patients participating in interventional clinical studies with Quality of Life as primary endpoint.\n* Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT03515993', 'briefTitle': 'Follow-up in Gynecological Cancer Survivors', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study', 'orgStudyIdInfo': {'id': 'EORTC-1514-QLG-GCG'}}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Chretien (CHC) - CHC MontLegia', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Merksem', 'country': 'Belgium', 'facility': 'ZNA Jan Palfijn', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig-Holstein - Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Wuppertal', 'country': 'Germany', 'facility': 'HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'city': 'Monza', 'country': 'Italy', 'facility': 'Ospedale San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ordine Mauriziano di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '11941', 'city': 'Amman', 'country': 'Jordan', 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': 'NL 6525', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc - Radboud University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': 'NL 3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC-Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'PL 80 211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University Of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': 'CT9 4AN', 'city': 'Margate', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'zip': 'NN1 5BD', 'city': 'Cliftonville', 'state': 'Northampton', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital NHS Trust', 'geoPoint': {'lat': 54.61667, 'lon': -5.93333}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}