Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT01825005
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2013-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Outcome in Cervix Carcinoma: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'five-year overall survival rate', 'timeFrame': '5 years after treatment', 'description': 'assessment of the overall survival 5 years after treatment'}], 'secondaryOutcomes': [{'measure': 'three-year distant disease free survival', 'timeFrame': '3 years', 'description': 'assessment of distant disease free survival, 3 years after treatment'}, {'measure': 'three-year local disease free survival', 'timeFrame': '3 years', 'description': 'assessment of local disease free survival, 3 year after treatment'}, {'measure': 'five-year distant disease free survival', 'timeFrame': '5 years', 'description': 'assessment of distant disease free survival,5 years after treatment'}, {'measure': 'five-year local disease free survival', 'timeFrame': '5 years', 'description': 'assessment of local disease free survival, 5 years after treatment'}, {'measure': 'number of participants with early adverse events as a measure of safety and tolerability', 'timeFrame': '2 months'}, {'measure': 'number of participants with late adverse events as a measure of safety and tolerability', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cervical cancer'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with cervical cancer can be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological or cytological proven cervical cancer\n* informed consent according to national rules\n\nExclusion Criteria:\n\n* no histological or cytological proven cervical cancer\n* no informed consent according to national rules'}, 'identificationModule': {'nctId': 'NCT01825005', 'acronym': 'POCER', 'briefTitle': 'Predicting Outcome in Cervix Carcinoma: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'Predicting Outcome in Cervix Carcinoma: a Prospective Study', 'orgStudyIdInfo': {'id': '12-4-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1:surgery', 'description': 'treatment = surgery only'}, {'label': 'group 2: radiotherapy', 'description': 'treatment = radiotherapy only'}, {'label': 'group 3: RT and CT, and/or hyperthermia', 'description': 'treatment= radiotherapy combined with chemotherapy and/or hyperthermia'}, {'label': 'group 4: stage IVb , any treatment', 'description': 'cervical cancer stage IV b, treatment = any systemic or radiation therapy and supportive care'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Bloemfontein medicross', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}], 'overallOfficials': [{'name': 'P Lambin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University hospital, dep of radiotherapy (Maastro clinic)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}