[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-i-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-i-ovarian-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100570640","a-prospective-multicenter-diagnostic-biomarker-study-to-discriminate-borderline-from-stage-i-invasive-ovarian-cancer-100570640",false,"NCT06709872","A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer","Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study","BIOC","Inclusion Criteria:\n\n* Participants eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n  2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n  3. Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment)\n\nExclusion Criteria:\n\n* Participants eligible for this Study must not meet any of the following criteria:\n\n  1. Participants younger than 18 years old,\n  2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive\n  3. Participants who refuse the preoperative transvaginal ultrasonography and\u002For blood sample\n  4. Participants with known simultaneous and\u002For previous malignancies within five years prior to BIOC participation\n  5. Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)\n  6. Participants who deny or withdraw the written informed consent","FEMALE","18 Years",{"count":20,"type":21},400,"ESTIMATED","1 Day","OBSERVATIONAL","The study aims to improve the diagnosis of ovarian cancer by distinguishing between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Other than the traditional diagnostic biomarker CA125, the previous study TRANS-IOTA (translational-international ovarian tumor analysis; S51375\u002FS59207), conducted by similar investigators, pointed at biomarkers like HE4, CA72.4, CA15.3, and CCL11, as potential markers to discriminate BOT from stage I cancer. BIOC is the follow-up study, which will include four additional promising biomarkers to expand the panel to nine. The investigators aim to confirm whether a subpanel of these nine biomarkers has diagnostic value. Such a biomarker signature would enhance the accuracy of distinguishing between BOT and stage I invasive ovarian cancer before surgery, leading to more precise treatment and improved patient outcomes.",[26,27],"Stage I Ovarian Cancer","Borderline Ovarian Tumors",[29,30,31,32],"Borderline ovarian tumors","stage I ovarian cancer","diagnostic","biomarkers","RECRUITING","2026-05-19",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":37},"2025-06-03",{"date":41,"type":21},"2029-09-03",{"name":43,"class":44},"KU Leuven","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":72,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100423474","developing-a-test-of-uterine-lavage-for-the-detection-of-ovarian-cancer-100423474","NCT04794322","Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer","Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study","Inclusion Criteria:\n\n* Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)\n* Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian\u002Ffallopian tube cancer\n* Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy\n\nExclusion Criteria:\n\n* Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer\n* Inability to provide informed consent\n* Age less than 30 years\n* Inability to obtain the minimum amount of blood\n* Inability to obtain the minimum amount of uterine lavage sample\n* At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm\u002FdL)\n* Prior history of known ovarian or endometrial cancer\n* Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin\n* History of untreated high-grade cervical dysplasia (CIN3)\n* History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.\n* Currently pregnant\n* Known Lynch syndrome","30 Years",{"count":55,"type":21},250,"The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis.\n\nStatistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.",[58,59,60,61,26,62,63,64,65,66,67,68,69,70,71],"Ovarian Neoplasms","Ovarian Epithelial Carcinoma","Fallopian Tube Neoplasms","High Grade Ovarian Serous Adenocarcinoma","Stage II Ovarian Cancer","Stage III Ovarian Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8",[73,74,75,76,77,78,79,80,81,82],"Uterine Lavage","Tumor DNA","Serum proteins","Ovarian neoplasms","Ovarian epithelial carcinoma","Ovarian cancer","Ovarian epithelial cancer","Neoplasms","Ovarian diseases","Early detection","2025-09-10",{"date":85,"type":37},"2025-09-16",{"date":87,"type":37},"2020-04-13",{"date":89,"type":21},"2028-08-31",{"name":91,"class":44},"Massachusetts General Hospital",6]