[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522562":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":357,"collaborators":360,"id":371,"slug":26,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":372,"sex":377,"minAge":378,"maxAge":379,"enrollmentInfo":380,"targetDuration":26,"studyType":383,"phases":384,"briefSummary":386,"conditions":387,"keywords":392,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Semi-annual surveillance using liver ultrasound +\u002F- alpha-fetoprotein","ACTIVE_COMPARATOR","Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.",[13],"Diagnostic Test: Liver Ultrasound with or without AFP",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: Semi-annual surveillance using GALAD","EXPERIMENTAL","For participants in this arm, study team will order GALAD measurement every 6 months +\u002F- 3 months.",[19],"Diagnostic Test: GALAD",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","GALAD","GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Liver Ultrasound with or without AFP","This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.",[9],[32],{"name":33,"affiliation":5,"role":34},"Amit Singal, MD, MS","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","214.645.8821","Amit.Singal@UTSouthwestern.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Sneha Deodhar, MS","214.645.1378","Sneha.Deodhar@UTSouthwestern.edu",[45,62,81,100,115,134,150,166,182,197,217,232,248,267,287,303,318,336],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Southern California","RECRUITING","Los Angeles","California","90089","United States",{"type":53,"coordinates":54},"Point",[55,56],-118.24368,34.05223,{"lat":56,"lon":55},[59,61],{"name":60,"role":37,"phone":26,"phoneExt":26,"email":26},"Kali Zhou, MD",{"name":60,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":63,"status":47,"city":64,"state":49,"zip":65,"country":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Stanford University","Redwood City","94063",{"type":53,"coordinates":67},[68,69],-122.23635,37.48522,{"lat":69,"lon":68},[72,76,80],{"name":73,"role":37,"phone":74,"phoneExt":26,"email":75},"Paul Kwo, MD","650-723-5135","pkwo@stanford.edu",{"name":77,"role":37,"phone":78,"phoneExt":26,"email":79},"Jennifer Smart","650-721-8517","Jsmart2@stanford.edu",{"name":73,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":82,"status":47,"city":83,"state":49,"zip":84,"country":51,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Kaiser Permanente","Roseville","95661",{"type":53,"coordinates":86},[87,88],-121.28801,38.75212,{"lat":88,"lon":87},[91,95,99],{"name":92,"role":37,"phone":93,"phoneExt":26,"email":94},"Sreepriya Balasubramanian, MD, MPH","916-474-6221","Sreepriya.Balasubramanian@kp.org",{"name":96,"role":37,"phone":97,"phoneExt":26,"email":98},"Quyen Chau","4158333468","Quyen.X.Chau@kp.org",{"name":92,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":101,"status":47,"city":102,"state":49,"zip":103,"country":51,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"University of California, San Francisco","San Francisco","94117",{"type":53,"coordinates":105},[106,107],-122.41942,37.77493,{"lat":107,"lon":106},[110,113],{"name":111,"role":37,"phone":26,"phoneExt":26,"email":112},"Rae Davis","rayshawnda.davis@ucsf.edu",{"name":114,"role":34,"phone":26,"phoneExt":26,"email":26},"Neil Mehta, MD",{"facility":116,"status":47,"city":117,"state":118,"zip":119,"country":51,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Northwestern University","Chicago","Illinois","60611",{"type":53,"coordinates":121},[122,123],-87.65005,41.85003,{"lat":123,"lon":122},[126,130,133],{"name":127,"role":37,"phone":128,"phoneExt":26,"email":129},"Laura Kulik, MD","312-694-1293","laura.kulik@nm.org",{"name":131,"role":37,"phone":128,"phoneExt":26,"email":132},"Kimberly Sipich","k-sipich@northwestern.edu",{"name":127,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":135,"status":47,"city":136,"state":137,"zip":138,"country":51,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Indiana University","Indianapolis","Indiana","46202",{"type":53,"coordinates":140},[141,142],-86.15804,39.76838,{"lat":142,"lon":141},[145,148],{"name":146,"role":37,"phone":26,"phoneExt":26,"email":147},"Sherri Cummins","shcummin@iu.edu",{"name":149,"role":34,"phone":26,"phoneExt":26,"email":26},"Naga Chalasani, MD",{"facility":151,"status":47,"city":152,"state":153,"zip":154,"country":51,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":53,"coordinates":156},[157,158],-71.05977,42.35843,{"lat":158,"lon":157},[161,164],{"name":162,"role":37,"phone":26,"phoneExt":26,"email":163},"Megan Michta","MMICHTA@mgh.harvard.edu",{"name":165,"role":34,"phone":26,"phoneExt":26,"email":26},"Irun Bhan, MD",{"facility":167,"status":47,"city":168,"state":169,"zip":170,"country":51,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"University of Michigan","Ann Arbor","Michigan","48109",{"type":53,"coordinates":172},[173,174],-83.74088,42.27756,{"lat":174,"lon":173},[177,180],{"name":178,"role":37,"phone":26,"phoneExt":26,"email":179},"Shay Robison","roshay@med.umich.edu",{"name":181,"role":34,"phone":26,"phoneExt":26,"email":26},"Neehar Parikh, MD, MS",{"facility":183,"status":47,"city":184,"state":169,"zip":185,"country":51,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Henry Ford Health System","Detroit","48202",{"type":53,"coordinates":187},[188,189],-83.04575,42.33143,{"lat":189,"lon":188},[192,195],{"name":193,"role":37,"phone":26,"phoneExt":26,"email":194},"Jessica Peruski","jperusk1@hfhs.org",{"name":196,"role":34,"phone":26,"phoneExt":26,"email":26},"Reena Salgia, MD",{"facility":198,"status":47,"city":199,"state":200,"zip":201,"country":51,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Hennepin Healthcare","Minneapolis","Minnesota","55415",{"type":53,"coordinates":203},[204,205],-93.26384,44.97997,{"lat":205,"lon":204},[208,212,216],{"name":209,"role":37,"phone":210,"phoneExt":26,"email":211},"Jose Debes, MD","952-737-9762","debes003@umn.edu",{"name":213,"role":37,"phone":214,"phoneExt":26,"email":215},"Daniel Akah","9527379762","Dakah@bermancenter.org",{"name":209,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":218,"status":47,"city":199,"state":200,"zip":219,"country":51,"cosmosGeoPoint":220,"geoPoint":222,"contacts":223},"University of Minnesota","55455",{"type":53,"coordinates":221},[204,205],{"lat":205,"lon":204},[224,228,231],{"name":225,"role":37,"phone":226,"phoneExt":26,"email":227},"Elizabeth Aby, MD","612-625-8999","abyxx002@umn.edu",{"name":229,"role":37,"phone":26,"phoneExt":26,"email":230},"Erin Wesley","wesle091@umn.edu",{"name":225,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":233,"status":47,"city":234,"state":235,"zip":236,"country":51,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"The Feinstein Institutes, Northwell Health, Inc.","Manhasset","New York","11030",{"type":53,"coordinates":238},[239,240],-73.69957,40.79788,{"lat":240,"lon":239},[243,246],{"name":244,"role":37,"phone":26,"phoneExt":26,"email":245},"Dibnain Nanda","dnanda1@northwell.edu",{"name":247,"role":34,"phone":26,"phoneExt":26,"email":26},"Sanjaya Satapathy, MBBS, MS",{"facility":249,"status":47,"city":250,"state":251,"zip":252,"country":51,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":53,"coordinates":254},[255,256],-79.05584,35.9132,{"lat":256,"lon":255},[259,263,266],{"name":260,"role":37,"phone":261,"phoneExt":26,"email":262},"Andrew Moon, MD","919-843-5936","Andrew.Moon@unchealth.unc.edu",{"name":264,"role":37,"phone":261,"phoneExt":26,"email":265},"Bhagyashree Behera","BB_Behera@med.unc.edu",{"name":260,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":268,"status":47,"city":269,"state":270,"zip":271,"country":51,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Case Western Reserve University","Cleveland","Ohio","44106",{"type":53,"coordinates":273},[274,275],-81.69541,41.4995,{"lat":275,"lon":274},[278,282,286],{"name":279,"role":37,"phone":280,"phoneExt":26,"email":281},"Pierre Gholam, MD","216-286-6757","pierre.gholam@case.edu",{"name":283,"role":37,"phone":284,"phoneExt":26,"email":285},"Paul Harris","216.983.5144","Paul.Harris2@UHhospitals.org",{"name":279,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":288,"status":47,"city":289,"state":290,"zip":291,"country":51,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":53,"coordinates":293},[294,295],-75.16362,39.95238,{"lat":295,"lon":294},[298,301],{"name":299,"role":37,"phone":26,"phoneExt":26,"email":300},"Grace Kim","gracekim.lee@pennmedicine.upenn.edu",{"name":302,"role":34,"phone":26,"phoneExt":26,"email":26},"Jorge Marrero, MD,MS",{"facility":304,"status":47,"city":305,"state":306,"zip":307,"country":51,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"UT Southwestern Medical Center and Parkland Hospital","Dallas","Texas","75390",{"type":53,"coordinates":309},[310,311],-96.80667,32.78306,{"lat":311,"lon":310},[314,317],{"name":41,"role":37,"phone":315,"phoneExt":26,"email":316},"214-645-1378","TRACER@UTSouthwestern.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":319,"status":47,"city":320,"state":306,"zip":321,"country":51,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Baylor College of Medicine","Houston","77021",{"type":53,"coordinates":323},[324,325],-95.36327,29.76328,{"lat":325,"lon":324},[328,332,334],{"name":329,"role":37,"phone":330,"phoneExt":26,"email":331},"Emad Sorial","713-798-7370","Emad.Sorial@bcm.edu",{"name":26,"role":37,"phone":26,"phoneExt":26,"email":333},"Sara.Fares@bcm.edu",{"name":335,"role":34,"phone":26,"phoneExt":26,"email":26},"Fasiha Kanwal, MD, MSHS",{"facility":337,"status":338,"city":339,"state":340,"zip":341,"country":51,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Virginia Commonwealth University","NOT_YET_RECRUITING","Richmond","Virginia","23219",{"type":53,"coordinates":343},[344,345],-77.46026,37.55376,{"lat":345,"lon":344},[348,352,356],{"name":349,"role":37,"phone":350,"phoneExt":26,"email":351},"Hannah Lee, MD","804-828-4060","Hannah.Lee@vcuhealth.org",{"name":353,"role":37,"phone":354,"phoneExt":26,"email":355},"Hannah Cook","804-628-9312","Hannah.Cook1@vcuhealth.org",{"name":349,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":358,"investigatorTitle":359,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amit Singal","Professor",[361,364,365,366,368,369],{"name":362,"class":363},"National Cancer Institute (NCI)","NIH",{"name":288,"class":6},{"name":167,"class":6},{"name":367,"class":6},"Dana-Farber Cancer Institute",{"name":319,"class":6},{"name":370,"class":6},"Fred Hutchinson Cancer Center","100522562",false,"NCT06084234","National Liver Cancer Screening Trial","TRACER","Inclusion Criteria:\n\nPatient must meet all of the following inclusion criteria:\n\n1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment\n2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator\n3. Able to provide informed consent\n4. Life expectancy \\>6 months (after consent) as determined by the treating provider or site investigator\n\nExclusion Criteria:\n\nPatient will be excluded for any of the following exclusion criteria:\n\n1. Child Pugh C cirrhosis\n2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma\n3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT\u002FMRI demonstrating benign nature)\n4. AFP \\>20 ng\u002FmL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions\n5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent\n6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent\n7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent\n8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward\n9. History of a transjugular intrahepatic portosystemic shunt (TIPS)\n10. History of Fontan associated liver disease or cardiac cirrhosis\n11. History of solid organ transplantation\n12. Actively listed for liver transplantation\n13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent\n14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)\n15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent\n16. Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)\n17. In patients living with HIV: CD4+ T cell count less than 100 cells\u002Fmm3 within 60 days prior to consent\n18. Known pregnancy at consent\n19. Active warfarin use","ALL","18 Years","85 Years",{"count":381,"type":382},5500,"ESTIMATED","INTERVENTIONAL",[385],"PHASE4","The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.",[388,389,390,391],"Carcinoma, Hepatocellular","Liver Cancer","Liver Cirrhosis","Hepatitis B",[393,23,394],"Hepatocellular carcinoma surveillance","Alpha Fetoprotein","2025-11-25",{"date":397,"type":398},"2025-11-26","ACTUAL",{"date":400,"type":398},"2023-12-26",{"date":402,"type":382},"2034-12-31",{"name":5,"class":6},18]