Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05043220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2021-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance', 'timeFrame': '3 months', 'description': 'Compliance is defined as wearing time of the in-ear-sensor.'}, {'measure': 'robustness of the ppg-signal', 'timeFrame': '3 months', 'description': 'number and duration of the ppg-signal transmitted'}], 'secondaryOutcomes': [{'measure': 'number of correct- and false-positive alerts', 'timeFrame': '3 months', 'description': 'definition via comparison of alerts with clinical data'}, {'measure': 'number of contacts and hospitalization rates', 'timeFrame': '3 months', 'description': 'definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data'}, {'measure': 'infections', 'timeFrame': '3 months', 'description': 'detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.'}, {'measure': 'therapy modifications', 'timeFrame': '3 months', 'description': 'dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation'}, {'measure': 'effect on quality of life', 'timeFrame': '3 months', 'description': 'change in minimum 9 points in the EORTC QLQ-C30-questionnaire is evaluated as significant change. In questions 1-28: 28-112 points can be achieved: higher scores are associated with a worse outcome. In questions 29-30:2-14 points can be achieved: higher scores are associated with a better outcome.'}, {'measure': 'OS; PFS', 'timeFrame': '3 months', 'description': 'time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)'}, {'measure': 'health-related costs', 'timeFrame': '3 months', 'description': 'cost-effectiveness analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telemedicine']}, 'descriptionModule': {'briefSummary': 'We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gynecological cancer\n* indication for systemic cancer therapy\n* patients who are legally competent and able to understand and follow instructions of the study staff\n* present informed consent\n\nExclusion Criteria:\n\n* no use if internet or applications\n* persons who are in a dependency or employment relationship with the study center\n* positive proof of COVID-19\n* affection of the external auditory canal'}, 'identificationModule': {'nctId': 'NCT05043220', 'acronym': 'CO-SI-ONKO', 'briefTitle': 'Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie', 'orgStudyIdInfo': {'id': 'CO-SI-ONKO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine', 'description': 'Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app', 'interventionNames': ['Device: PPG and PROM']}], 'interventions': [{'name': 'PPG and PROM', 'type': 'DEVICE', 'description': 'description will follow', 'armGroupLabels': ['Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Frauenklinik, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Heike Jansen, Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Marion Kiechle, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Technical University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heike Jansen', 'investigatorAffiliation': 'Technical University of Munich'}}}}