[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604031":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group",null,"Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.",[13],"Device: HeLP TM",{"label":15,"type":10,"description":16,"interventionNames":17},"Case Group","Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","HeLP TM","lab test for prostate cancer",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Judd Moul, MD","CONTACT","919-684-5057","judd.moul@duke.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Durham","North Carolina","27710","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-78.89862,35.99403,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Hessian Labs Inc","UNKNOWN","100604031","validation-of-a-platelet-proteomic-assay-for-diagnosing-and-monitoring-prostate-cancer-100604031",false,"NCT07144228","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer","Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.","Eligibility criteria\n\n* Patients ≥ 40 years of age\n* All patients with suspicion of PCa\n\nMen ≥ 40 years of age attending Duke Health\u002FUrology with suspicion of prostate cancer (Primary disease) will be approached to consent for the study. Upon consent, samples will be obtained alone, during repeat PSA\u002Fother biomarkers testing, or during imaging at Duke Lab.\n\nExclusion criteria\n\n* Men who have previously undergone treatment for prostate cancer.\n* Men with prior diagnosis of prostate cancer.\n* Men with severe, irreversible coagulopathy.\n* Men on anticoagulant therapies or those who have taken antiplatelet agents such as aspirin, NSAIDs (ibuprofen, entrophen, naproxen, diclofenac etc), clopidrogel, prasugrel, ticagrelor, or dipyridamole in the 7 days preceding blood collection.","MALE","40 Years",{"count":62,"type":63},300,"ESTIMATED","OBSERVATIONAL","This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative.\n\nThe study is inviting men who are being seen for suspicion of prostate cancer (based on symptoms or previous lab results). If they agree to be in the study, the research team will take a sample of their blood at the time they are getting a repeat PSA test or having Imaging. The research test does not affect the care they are already receiving and takes 3 extra tubes of blood (\\~3 tbsp).\n\nThe research team is aiming to include 300 participants total. They believe 278 people are needed to confidently compare results between people with and without prostate cancer.\n\nThey will do an interim analysis halfway through the study, once samples from 150 subjects have been collected.\n\nThe research is considered low risk-no more uncomfortable or dangerous than a blood draw. There is a risk of loss of privacy, but researchers are taking strong steps to protect privileged information. That includes proper data handling, secure, storage, and making sure the study team is trained in research ethics.",[67],"Prostate Cancer (Diagnosis)","2026-03-17",{"date":70,"type":71},"2026-03-19","ACTUAL",{"date":73,"type":71},"2026-03-11",{"date":75,"type":63},"2028-09-30",{"name":5,"class":6},1]