Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
Study NCT ID:
NCT06839157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-02-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence - Assisted Model for Optimal Timing of Surgery in Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4489}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).', 'timeFrame': '3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian, Fallopian, and Primary Peritoneal Cancer', 'Artificial Intelligence (AI)']}, 'descriptionModule': {'briefSummary': 'This study integrates data from the randomized controlled SUNNY trial (RCT) and real-world (RWD) data, and employs multimodal data fitting to construct a medical artificial intelligence model to identify the clinical characteristics of patient subgroups suitable for primary debulking surgery (PDS) or interval debulking surgery (IDS), and the cutoff values for selecting different timings of surgery for advanced ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)\n* Underwent primary debulking surgery or interval debulking surgery\n* Data avaliable on first-line treatment and follow-up\n\nExclusion Criteria:\n\n* Non-epithelial ovarian cancer or borderline tumors.\n* Low-grade tumors.\n* Mucinous ovarian cancer.\n* Missing data on first-line treatment and follow-up'}, 'identificationModule': {'nctId': 'NCT06839157', 'briefTitle': 'Artificial Intelligence - Assisted Model for Optimal Timing of Surgery in Advanced Ovarian Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Gynecologic Oncology Group'}, 'officialTitle': 'An Artificial Intelligence - Assisted Model for Predicting Optimal Timing of Surgery in Advanced Ovarian Cancer: the Combined Study of the SUNNY Trial and the Real World Data', 'orgStudyIdInfo': {'id': 'SUNNY-AI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1- SUNNY RCT Trial', 'description': '489 patients who were enrolled and randomized in the SUNNY RCT trials.'}, {'label': 'Cohort 2- Pragmatic Trial', 'description': '4000 patients who were newly diagnosed as stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 2015 and 2024'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Gynecologic Oncology Group', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)', 'class': 'UNKNOWN'}, {'name': 'Sun Yat-sen University Cancer Centre', 'class': 'UNKNOWN'}, {'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}