[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sequenom, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,67,86,107,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634751","prostate-cancer-risk-identification-in-a-multi-ethnic-cohort-a-prospective-us-based-multi-center-validation-study-of-proclarix-100634751",false,"NCT07543757","Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix","PRIME","Inclusion Criteria:\n\n1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;\n2. Subject provides a signed and dated informed consent;\n3. Subject has a SOC tPSA of 2-10 ng\u002FmL inclusive within 30 days of the Screening Visit;\n\n   1. Up to 100 subjects will have a SOC tPSA of 2-\\\u003C4 ng\u002FmL\n   2. A minimum of 400 subjects will have a SOC tPSA of 4-10 ng\u002FmL\n4. Subject is scheduled to undergo a prostate biopsy within 30 days of the Screening Visit blood collection;\n5. Subject agrees to provide all diagnostic test results throughout the study; and\n6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.\n\nExclusion Criteria:\n\n\\-","MALE","40 Years","75 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Prostate biopsy will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores are required. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy. The assay results will be compared to the biopsy results.",[25],"Prostate Cancer Detection",[27],"prostate cancer, screening","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":32},"2026-04-03",{"date":36,"type":21},"2027-03-31",{"name":38,"class":39},"Sequenom, Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100565558","non-invasive-preeclampsia-screening-and-biobank-100565558","NCT06643741","Non-Invasive Preeclampsia Screening and Biobank","Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia","Inclusion Criteria:\n\n* Subject is female and 18 years of age and older;\n* Subject provides a signed and dated informed consent;\n* Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;\n* Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;\n* Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;\n* Subject agrees to provide up to 25mL of whole blood at each trimester visit;\n* Subject agrees to provide relevant medical and pregnancy\u002Fpostnatal information including outcome.\n\nExclusion Criteria:\n\n* Subject is unlikely to return for second and third trimester testing;\n* Subject is unlikely to have pregnancy outcome data available;\n* Previous sample donation under this protocol with the same pregnancy;\n* Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.",true,"FEMALE","18 Years",{"count":52,"type":21},6550,"6 Months","Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.",[56],"Preeclampsia (PE)",[58,59],"preeclampsia","pregnant",{"date":31,"type":32},{"date":62,"type":32},"2025-02-02",{"date":64,"type":21},"2026-07-01",{"name":38,"class":39},21,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},"100408186","clinical-follow-up-of-pregnant-subjects-undergoing-nipt-100408186","NCT04595201","Clinical Follow-up of Pregnant Subjects Undergoing NIPT","Inclusion Criteria:\n\n* Subject was pregnant and received NIPT from Sequenom\u002FIntegrated Genetics\n* Subject was 18 years of age or older at the time of NIPT\n* Pregnancy outcome is available\n\nExclusion Criteria:\n\n* None",{"count":74,"type":21},25000,"To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).",[77],"Pregnancy","2024-10-11",{"date":80,"type":32},"2024-10-16",{"date":82,"type":32},"2020-10-13",{"date":84,"type":21},"2025-10-13",{"name":38,"class":39},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":48,"sex":93,"minAge":4,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":40},"100390482","compliant-analysis-of-patient-samples-and-data-100390482","NCT04364503","Compliant Analysis of Patient Samples and Data","Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And\u002For Population-based Analysis","Inclusion Criteria:\n\n* Arm 1\n* All samples and data are de-identified and HIPAA compliant\n* Arm 2\n* Subject is of scientific interest to the Sponsor or treating physician\n* Subject provides written informed consent and has a clinical sample and\u002For supporting clinical data collected.\n\nExclusion Criteria:\n\n* Arm 1\n* Subject is from a US state or a country where local law restricts the use of de-identified data and\u002For remnants of specimens for research and\u002For development\n* Arm 2\n* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent","ALL",{"count":95,"type":21},2000,"Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and\u002For data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.",[98,99,100],"Pregnancy Related","Cancer","Infectious Disease",{"date":80,"type":32},{"date":103,"type":32},"2018-03-17",{"date":105,"type":21},"2030-08-15",{"name":38,"class":39},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":93,"minAge":50,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":40},"100254087","specimen-collection-from-patients-with-non-hematologic-cancer-for-use-in-development-of-a-liquid-biopsy-assay-100254087","NCT02586389","Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay","Collection of Whole Blood and Tissue Specimens from Patients Diagnosed with Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA","Inclusion Criteria:\n\n* Subject is 18 years of age or older;\n* Subject is willing to provide written informed consent;\n* Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either;\n\n  1. residual tumor tissue available for testing by the Sponsor; or\n  2. genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or\n  3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor.\n* Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits.\n\nExclusion Criteria:\n\n* Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit.\n* Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit.\n* Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up).\n* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.",{"count":115,"type":21},3000,"This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).",[118],"Non-hematologic Cancer",{"date":80,"type":32},{"date":121,"type":32},"2015-10-13",{"date":123,"type":21},"2027-10-31",{"name":38,"class":39},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100165642","specimen-collection-from-pregnant-women-at-increased-risk-for-fetal-aneuploidy-100165642","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",{"count":95,"type":21},"The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.",[135,136],"Down Syndrome","Fetal Aneuploidy",[138,139,140,141],"Down syndrome","fetal aneuploidy","trisomy","noninvasive screening test",{"date":80,"type":32},{"date":144,"type":32},"2011-05",{"date":146,"type":21},"2026-03",{"name":38,"class":39},14,""]