[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423474":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":143,"collaborators":146,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":10,"eligibilityCriteria":174,"healthyVolunteers":170,"sex":175,"minAge":176,"maxAge":10,"enrollmentInfo":177,"targetDuration":10,"studyType":180,"phases":10,"briefSummary":181,"conditions":182,"keywords":198,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pelvic Mass Cohort (cohort #1)",null,"200 participants scheduled for surgery for suspected ovarian cancer due to a pelvic mass but without a confirmed tissue or cytology diagnosis.",[13,14,15],"Diagnostic Test: Uterine lavage, or a wash of the womb","Diagnostic Test: Blood sample","Diagnostic Test: Pap smear",{"label":17,"type":10,"description":18,"interventionNames":19},"BRCA1\u002F2 Carriers Cohort (cohort #2)","50 participants with an inherited BRCA1 or BRCA2 deleterious mutation without suspected ovarian cancers who are scheduled for risk-reducing salpingo-oophorectomy (RRSO) to remove ovaries and fallopian tubes.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Uterine lavage, or a wash of the womb","Uterine lavage is performed during surgery using a flexible, 3-way balloon tipped catheter. The catheter is inserted through the cervix, the balloon expanded and the uterine cavity lavaged using 10 cc of sterile saline which is collected, processed and stored for later analysis.",[17,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Blood sample","Participants undergo two blood draws (one required, one optional) up to 31 days before surgery",[17,9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Pap smear","Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.",[17,9],[35],{"name":36,"affiliation":37,"role":38},"Christos Patriotis, PhD","National Cancer Institute (NCI)","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Jackie Dahlgren","CONTACT","206 667 3438","jdahlgre@fredhutch.org",[46,68,79,96,110,126],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Arkansas for Medical Sciences","RECRUITING","Little Rock","Arkansas","72205","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-92.28959,34.74648,{"lat":58,"lon":57},[61,65],{"name":62,"role":42,"phone":63,"phoneExt":10,"email":64},"Beth Scanlan","501-686-8274","BScanlan@uams.edu",{"name":66,"role":67,"phone":10,"phoneExt":10,"email":10},"Kristin Zorn, MD","PRINCIPAL_INVESTIGATOR",{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":52,"countryCode":53,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Kaiser Permanente - San Francisco","ACTIVE_NOT_RECRUITING","San Francisco","California","94115",{"type":55,"coordinates":75},[76,77],-122.41942,37.77493,{"lat":77,"lon":76},{"facility":80,"status":48,"city":81,"state":82,"zip":83,"country":52,"countryCode":53,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Anne Arundel Health System","Annapolis","Maryland","21401",{"type":55,"coordinates":85},[86,87],-76.49184,38.97859,{"lat":87,"lon":86},[90,94],{"name":91,"role":42,"phone":92,"phoneExt":10,"email":93},"Jaci Miller","443-481-5738","jmiller9@aahs.org",{"name":95,"role":67,"phone":10,"phoneExt":10,"email":10},"Monica Jones, MD",{"facility":97,"status":48,"city":98,"state":82,"zip":99,"country":52,"countryCode":53,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Johns Hopkins University School of Medicine","Baltimore","21218",{"type":55,"coordinates":101},[102,103],-76.61219,39.29038,{"lat":103,"lon":102},[106,109],{"name":107,"role":42,"phone":10,"phoneExt":10,"email":108},"Rebecca Stone, MD","rstone15@jhmi.edu",{"name":107,"role":67,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":48,"city":111,"state":112,"zip":113,"country":52,"countryCode":53,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Boston","Massachusetts","02114",{"type":55,"coordinates":115},[116,117],-71.05977,42.35843,{"lat":117,"lon":116},[120,124],{"name":121,"role":42,"phone":122,"phoneExt":10,"email":123},"Tina Colella","617-643-5150","tcolella@partners.org",{"name":125,"role":67,"phone":10,"phoneExt":10,"email":10},"Amy Bregar, MD",{"facility":127,"status":48,"city":128,"state":129,"zip":130,"country":52,"countryCode":53,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"The Swedish Hospital","Seattle","Washington","98122",{"type":55,"coordinates":132},[133,134],-122.33207,47.60621,{"lat":134,"lon":133},[137,141],{"name":138,"role":42,"phone":139,"phoneExt":10,"email":140},"Robert Pearhill","206-667-3278","rpearhil@fredhutch.org",{"name":142,"role":67,"phone":10,"phoneExt":10,"email":10},"Charles Drescher, MD",{"type":67,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Steven Skates","Principal Investigator",[147,149,151,153,155,157,159,161,163,165],{"name":148,"class":6},"Johns Hopkins University",{"name":150,"class":6},"Fred Hutchinson Cancer Center",{"name":152,"class":6},"Anne Arundel Health System Research Institute",{"name":154,"class":6},"University of Arkansas",{"name":37,"class":156},"NIH",{"name":158,"class":6},"Kaiser Permanente",{"name":160,"class":6},"McGill University",{"name":162,"class":6},"M.D. Anderson Cancer Center",{"name":164,"class":6},"Swedish Medical Center",{"name":166,"class":167},"Early Detection Research Network","NETWORK","100423474","developing-a-test-of-uterine-lavage-for-the-detection-of-ovarian-cancer-100423474",false,"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","FEMALE","30 Years",{"count":178,"type":179},250,"ESTIMATED","OBSERVATIONAL","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.",[183,184,185,186,187,188,189,190,191,192,193,194,195,196,197],"Ovarian Neoplasms","Ovarian Epithelial Carcinoma","Fallopian Tube Neoplasms","High Grade Ovarian Serous Adenocarcinoma","Stage I Ovarian Cancer","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",[199,200,201,202,203,204,205,206,207,208],"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":211,"type":212},"2025-09-16","ACTUAL",{"date":214,"type":212},"2020-04-13",{"date":216,"type":179},"2028-08-31",{"name":5,"class":6},6]