Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT06279104
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tumor response rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1'}], 'secondaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the time from therapy initiation to the first documented progression or death from any cause, whichever occurred first'}, {'measure': 'time to response (TTR)', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'the time from therapy initiation to the first documented complete response or partial response'}, {'measure': 'duration of response (DOR)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the time from the first documented response to disease progression or death, whichever occurs first'}, {'measure': 'disease control rate (DCR)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the proportion of patients with complete response, partial response, and stable disease'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian clear cell carcinoma', 'real world study', 'immune checkpoint inhibitor'], 'conditions': ['Ovarian Clear Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:\n\n* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?\n* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?\n* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?\n\nParticipants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed/persistent OCCC were extracted de-identified, longitudinal electronic health records (EHR)-derived data from 12 tertiary hospitals in China since October 2008. Consecutive patients were enrolled with no restriction on treatment regimens.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients with age ≥ 18 years old and ≤ 75 years old.\n2. There must be a histological diagnosis of ovarian clear cell carcinoma.\n3. Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.\n5. Expected survival time ≥ 12 weeks.\n\nExclusion Criteria:\n\n1.Histological evidence of non-ovarian clear cell carcinoma.'}, 'identificationModule': {'nctId': 'NCT06279104', 'briefTitle': 'A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary', 'orgStudyIdInfo': {'id': '2023-TJ-OCCC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'real-world study (RWS)-Chemotherapy', 'interventionNames': ["Drug: physician's choice of chemotherapy"]}, {'label': 'RWS-ICI', 'interventionNames': ['Drug: immune checkpoint inhibitor based therapy']}], 'interventions': [{'name': "physician's choice of chemotherapy", 'type': 'DRUG', 'description': "physician's choice of chemotherapy for relapsed/refractory ovarian clear cell carcinoma", 'armGroupLabels': ['real-world study (RWS)-Chemotherapy']}, {'name': 'immune checkpoint inhibitor based therapy', 'type': 'DRUG', 'description': 'immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma', 'armGroupLabels': ['RWS-ICI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qinglei Gao, PhD, MD', 'role': 'CONTACT', 'email': 'qingleigao@hotmail.com', 'phone': '+86-13871127473'}, {'name': 'Qinglei Gao, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qinglei Gao, PhD', 'role': 'CONTACT', 'email': 'qingleigao@hotmail.com', 'phone': '+86 13871127473'}]}, 'ipdSharingStatementModule': {'url': 'http://nuwa.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The individual participant data will be available (including data dictionaries). The individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) in particular will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Hubei Cancer Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Suzhou Medical College', 'class': 'OTHER'}, {'name': 'Shandong Tumor Hospital', 'class': 'OTHER'}, {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Zhongshan Medical University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Qinglei Gao', 'investigatorAffiliation': 'Tongji Hospital'}}}}