[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638338":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":52,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":10,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":10,"maxAge":10,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":105,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ovarian Cancer",null,"Women with ovarian cancer who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and\u002For pathological diagnosis. This cohort will be used to evaluate the sensitivity of the assay, including its performance in different histologic subtypes and early-stage disease.",[13],"Diagnostic Test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection",{"label":15,"type":10,"description":16,"interventionNames":17},"Benign Gynecologic Diseases","Women with benign gynecologic diseases who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and\u002For pathological diagnosis. This cohort will be used to evaluate the specificity of the assay.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection","A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and\u002For pathological diagnoses to evaluate diagnostic performance.",[15,9],[25],"Plasma cfDNA Methylation Test",[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Qinglei Gao, Dr.","CONTACT","+86-27-83662681","qingleigao@hotmail.com",[33],{"facility":34,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology","Wuhan","Hubei","430030","China","CN",{"type":41,"coordinates":42},"Point",[43,44],114.26667,30.58333,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Qinglei Gao","Dr.",[53,55,57,59,61,63,65,67,69,71,74,76],{"name":54,"class":6},"Women's Hospital School Of Medicine Zhejiang University",{"name":56,"class":6},"The Affiliated Hospital of Qingdao University",{"name":58,"class":6},"Shanghai First Maternity and Infant Hospital",{"name":60,"class":6},"The First Affiliated Hospital of Soochow University",{"name":62,"class":6},"Xiangyang Central Hospital",{"name":64,"class":6},"The First Hospital of Jilin University",{"name":66,"class":6},"Renmin Hospital of Wuhan University",{"name":68,"class":6},"General Hospital of Ningxia Medical University",{"name":70,"class":6},"Wuhan Central Hospital",{"name":72,"class":73},"The First Hospital of Lanzhou University, Gansu, China","UNKNOWN",{"name":75,"class":73},"Tongji Hospital affiliated to Tongji University",{"name":77,"class":6},"The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China","100638338","prospective-sample-collection-study-for-a-blood-based-cfdna-methylation-assay-for-ovarian-cancer-detection-100638338",false,"NCT07593833","Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection","Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer","Inclusion Criteria:\n\n* Female participants.\n* Participants with an ovarian\u002Fadnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy\u002Fpathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.\n* Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian\u002Fadnexal mass requiring differential diagnosis.\n* An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian\u002Fadnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.\n* Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.\n* The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.\n\nExclusion Criteria:\n\n* The participant has already received systemic anti-tumor treatment for the current ovarian\u002Fadnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.\n* No pathologic diagnosis is ultimately obtained for the current ovarian\u002Fadnexal mass, or no analyzable pathologic conclusion can be established.\n* Imaging findings at screening are highly typical of benign mature cystic teratoma.\n* Ovarian cancer combined with another malignant tumor.\n* There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","FEMALE",{"count":87,"type":88},1000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:\n\nHow well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?\n\nResearchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.\n\nParticipants will:\n\nProvide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis",[92,9,93],"Ovarian Neoplasms","Early Detection of Cancer",[9,92,95,96,97,98,99,100,101,102,103,104],"cfDNA Methylation","Cell-Free DNA","DNA Methylation","Liquid Biopsy","Blood-Based Assay","Early Detection","Biomarker","Early Diagnosis","Diagnostic Performance","Ovarian Tumor","NOT_YET_RECRUITING","2026-05-12",{"date":108,"type":109},"2026-05-18","ACTUAL",{"date":111,"type":88},"2026-07-01",{"date":113,"type":88},"2029-12-30",{"name":5,"class":6},1]