[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100165642":3},{"organization":4,"outcomesModule":7,"designInfo":8,"detailedDescription":11,"studyPopulation":12,"armGroups":7,"interventions":7,"overallOfficials":13,"centralContacts":7,"locations":17,"responsibleParty":241,"collaborators":7,"id":243,"slug":7,"hasResults":244,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":7,"eligibilityCriteria":248,"healthyVolunteers":244,"sex":249,"minAge":250,"maxAge":7,"enrollmentInfo":251,"targetDuration":7,"studyType":254,"phases":7,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":20,"whyStopped":7,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},{"fullName":5,"class":6},"Sequenom, Inc.","INDUSTRY",null,{"allocation":7,"interventionModel":7,"interventionModelDescription":7,"primaryPurpose":7,"observationalModel":9,"timePerspective":10,"maskingInfo":7},"CASE_ONLY","PROSPECTIVE","To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator\u002Fs for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and\u002For genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.","Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and\u002For QF-PCR results from the procedure.",[14],{"name":15,"affiliation":5,"role":16},"Daniel Grosu, MD","STUDY_DIRECTOR",[18,40,56,71,83,96,109,125,142,159,174,189,206,225],{"facility":19,"status":20,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"University of Alabama Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":27,"coordinates":28},"Point",[29,30],-86.80249,33.52066,{"lat":30,"lon":29},[33,38],{"name":34,"role":35,"phone":36,"phoneExt":7,"email":37},"Rachel Copper","CONTACT","205 934-5509","rachel.copper@obgyn.uab.edu",{"name":39,"role":35,"phone":7,"phoneExt":7,"email":7},"Joseph Biggio, MD",{"facility":41,"status":20,"city":42,"state":43,"zip":44,"country":24,"countryCode":25,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Cedars-Sinai Medical Center","Los Angeles","California","90048",{"type":27,"coordinates":46},[47,48],-118.24368,34.05223,{"lat":48,"lon":47},[51,54],{"name":52,"role":35,"phone":53,"phoneExt":7,"email":7},"Deebra Smith, MD","310- 423-5860",{"name":55,"role":35,"phone":7,"phoneExt":7,"email":7},"John Williams, MD",{"facility":57,"status":20,"city":58,"state":43,"zip":59,"country":24,"countryCode":25,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Sharp-Rees Stealy Medical Group","San Diego","92101",{"type":27,"coordinates":61},[62,63],-117.16472,32.71571,{"lat":63,"lon":62},[66,69],{"name":67,"role":35,"phone":68,"phoneExt":7,"email":7},"Mary LaPage","619 446-1624",{"name":70,"role":35,"phone":7,"phoneExt":7,"email":7},"Denis Tarakjian, MD",{"facility":72,"status":20,"city":58,"state":43,"zip":73,"country":24,"countryCode":25,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"UCSD","92121",{"type":27,"coordinates":75},[62,63],{"lat":63,"lon":62},[78,81],{"name":79,"role":35,"phone":7,"phoneExt":7,"email":80},"Jason Chibuck","jchibuck@ucsd.edu",{"name":82,"role":35,"phone":7,"phoneExt":7,"email":7},"Andrew Hull, MD",{"facility":84,"status":20,"city":58,"state":43,"zip":85,"country":24,"countryCode":25,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Women's Health Care Research","92123",{"type":27,"coordinates":87},[62,63],{"lat":63,"lon":62},[90,94],{"name":91,"role":35,"phone":92,"phoneExt":7,"email":93},"Nora Martinez","858 505-8672","research@womenwellness.com",{"name":95,"role":35,"phone":7,"phoneExt":7,"email":7},"Rovena Reagan, MD",{"facility":97,"status":20,"city":58,"state":43,"zip":98,"country":24,"countryCode":25,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Specialty Obstetrics of San Diego","92130",{"type":27,"coordinates":100},[62,63],{"lat":63,"lon":62},[103,107],{"name":104,"role":35,"phone":105,"phoneExt":7,"email":106},"Deborah Malone","858 794-7700","d.malone@specialtyobstetrics.com",{"name":108,"role":35,"phone":7,"phoneExt":7,"email":7},"David Dowling, MD",{"facility":110,"status":20,"city":111,"state":112,"zip":113,"country":24,"countryCode":25,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Reproductive Genetics Institute","Chicago","Illinois","60602",{"type":27,"coordinates":115},[116,117],-87.65005,41.85003,{"lat":117,"lon":116},[120,123],{"name":121,"role":35,"phone":122,"phoneExt":7,"email":7},"Denise Ginsberg","773 472-4900",{"name":124,"role":35,"phone":7,"phoneExt":7,"email":7},"Norman Ginsberg, MD",{"facility":126,"status":20,"city":127,"state":128,"zip":129,"country":24,"countryCode":25,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University of Iowa Health Care","Iowa City","Iowa","52242",{"type":27,"coordinates":131},[132,133],-91.53017,41.66113,{"lat":133,"lon":132},[136,140],{"name":137,"role":35,"phone":138,"phoneExt":7,"email":139},"Diedre Fleener","319 356-2913","deidre-fleener@uiowa.edu",{"name":141,"role":35,"phone":7,"phoneExt":7,"email":7},"Kristi Borowski, MD",{"facility":143,"status":20,"city":144,"state":145,"zip":146,"country":24,"countryCode":25,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":27,"coordinates":148},[149,150],-83.04575,42.33143,{"lat":150,"lon":149},[153,157],{"name":154,"role":35,"phone":155,"phoneExt":7,"email":156},"Ellen Martindell","313 916-3190","emartin1@hfhs.org",{"name":158,"role":35,"phone":7,"phoneExt":7,"email":7},"Jacquelyn Roberson, MD",{"facility":160,"status":20,"city":161,"state":145,"zip":162,"country":24,"countryCode":25,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Spectrum Health","Grand 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Carolina","29466",{"type":27,"coordinates":195},[196,197],-79.93275,32.77632,{"lat":197,"lon":196},[200,204],{"name":201,"role":35,"phone":202,"phoneExt":7,"email":203},"Betty Oswald","843 792-0347","oswaldbw@musc.edu",{"name":205,"role":35,"phone":7,"phoneExt":7,"email":7},"Christopher Robinson, MD",{"facility":207,"status":20,"city":208,"state":209,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8","Canada","CA",{"type":27,"coordinates":214},[215,216],-63.57688,44.64269,{"lat":216,"lon":215},[219,223],{"name":220,"role":35,"phone":221,"phoneExt":7,"email":222},"Cora Fanning","902 470-7158","cora.fanning@iwk.nshealth.ca",{"name":224,"role":35,"phone":7,"phoneExt":7,"email":7},"Jo-Ann Brock, MD",{"facility":226,"status":20,"city":227,"state":228,"zip":7,"country":211,"countryCode":212,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"North York General Hospital","Toronto","Ontario",{"type":27,"coordinates":230},[231,232],-79.39864,43.70643,{"lat":232,"lon":231},[235,239],{"name":236,"role":35,"phone":237,"phoneExt":7,"email":238},"Clare Gibbons","416 756-6788","clare.gibbons@nygh.on.ca",{"name":240,"role":35,"phone":7,"phoneExt":7,"email":7},"Wendy Meschino, MD",{"type":242,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100165642",false,"NCT01429389","Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy","Collection of Whole Blood Specimens from Pregnant Women At Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma","Inclusion Criteria:\n\n* pregnant between 10 and 22 weeks gestation\n* 18 years of age or older\n* provides signed and dated informed consent\n* subject is at increased risk for fetal aneuploidy\n* subject is willing to undergo a CVS and\u002For amniocentesis procedure for the purpose of genetic analysis\n* subject agrees to provide the genetic results of the invasive procedure\n\nExclusion Criteria:\n\n* Fetal demise at time of specimen sampling\n* Previous sample donation under this protocol","FEMALE","18 Years",{"count":252,"type":253},2000,"ESTIMATED","OBSERVATIONAL","The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.",[257,258],"Down Syndrome","Fetal Aneuploidy",[260,261,262,263],"Down syndrome","fetal aneuploidy","trisomy","noninvasive screening test","2024-10-11",{"date":266,"type":267},"2024-10-16","ACTUAL",{"date":269,"type":267},"2011-05",{"date":271,"type":253},"2026-03",{"name":5,"class":6},14]