[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522562":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":369,"collaborators":372,"id":384,"slug":385,"hasResults":386,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":386,"sex":391,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":26,"studyType":397,"phases":398,"briefSummary":400,"conditions":401,"keywords":406,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},{"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},"Lisa Quirk, MS, MPH","214.645.6179","Lisa.Quirk@UTSouthwestern.edu",[45,63,82,101,116,135,151,167,183,198,217,232,248,267,287,299,315,331,349],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Southern California","RECRUITING","Los Angeles","California","90089","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-118.24368,34.05223,{"lat":57,"lon":56},[60,62],{"name":61,"role":37,"phone":26,"phoneExt":26,"email":26},"Kali Zhou, 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MPH","9164746221","Sreepriya.Balasubramanian@kp.org",{"name":97,"role":37,"phone":98,"phoneExt":26,"email":99},"Quyen Chau","4158333468","Quyen.X.Chau@kp.org",{"name":93,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":102,"status":47,"city":103,"state":49,"zip":104,"country":51,"countryCode":52,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University of California, San Francisco","San Francisco","94117",{"type":54,"coordinates":106},[107,108],-122.41942,37.77493,{"lat":108,"lon":107},[111,114],{"name":112,"role":37,"phone":26,"phoneExt":26,"email":113},"Rae Davis","rayshawnda.davis@ucsf.edu",{"name":115,"role":34,"phone":26,"phoneExt":26,"email":26},"Neil Mehta, MD",{"facility":117,"status":47,"city":118,"state":119,"zip":120,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Northwestern University","Chicago","Illinois","60611",{"type":54,"coordinates":122},[123,124],-87.65005,41.85003,{"lat":124,"lon":123},[127,131,134],{"name":128,"role":37,"phone":129,"phoneExt":26,"email":130},"Laura Kulik, MD","312-694-1293","laura.kulik@nm.org",{"name":132,"role":37,"phone":129,"phoneExt":26,"email":133},"Kimberly Sipich","k-sipich@northwestern.edu",{"name":128,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":136,"status":47,"city":137,"state":138,"zip":139,"country":51,"countryCode":52,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Indiana University","Indianapolis","Indiana","46202",{"type":54,"coordinates":141},[142,143],-86.15804,39.76838,{"lat":143,"lon":142},[146,149],{"name":147,"role":37,"phone":26,"phoneExt":26,"email":148},"Sherri Cummins","shcummin@iu.edu",{"name":150,"role":34,"phone":26,"phoneExt":26,"email":26},"Naga Chalasani, MD",{"facility":152,"status":47,"city":153,"state":154,"zip":155,"country":51,"countryCode":52,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":54,"coordinates":157},[158,159],-71.05977,42.35843,{"lat":159,"lon":158},[162,165],{"name":163,"role":37,"phone":26,"phoneExt":26,"email":164},"Megan Michta","MMICHTA@mgh.harvard.edu",{"name":166,"role":34,"phone":26,"phoneExt":26,"email":26},"Irun Bhan, MD",{"facility":168,"status":47,"city":169,"state":170,"zip":171,"country":51,"countryCode":52,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"University of Michigan","Ann Arbor","Michigan","48109",{"type":54,"coordinates":173},[174,175],-83.74088,42.27756,{"lat":175,"lon":174},[178,181],{"name":179,"role":37,"phone":26,"phoneExt":26,"email":180},"Shay Robison","roshay@med.umich.edu",{"name":182,"role":34,"phone":26,"phoneExt":26,"email":26},"Neehar Parikh, MD, MS",{"facility":184,"status":47,"city":185,"state":170,"zip":186,"country":51,"countryCode":52,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Henry Ford Health System","Detroit","48202",{"type":54,"coordinates":188},[189,190],-83.04575,42.33143,{"lat":190,"lon":189},[193,196],{"name":194,"role":37,"phone":26,"phoneExt":26,"email":195},"Jessica Peruski","jperusk1@hfhs.org",{"name":197,"role":34,"phone":26,"phoneExt":26,"email":26},"Reena Salgia, MD",{"facility":199,"status":47,"city":200,"state":201,"zip":202,"country":51,"countryCode":52,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Hennepin Healthcare","Minneapolis","Minnesota","55415",{"type":54,"coordinates":204},[205,206],-93.26384,44.97997,{"lat":206,"lon":205},[209,213,216],{"name":210,"role":37,"phone":211,"phoneExt":26,"email":212},"Jose Debes, MD","9527379762","debes003@umn.edu",{"name":214,"role":37,"phone":211,"phoneExt":26,"email":215},"Daniel Akah","Dakah@bermancenter.org",{"name":210,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":218,"status":47,"city":200,"state":201,"zip":219,"country":51,"countryCode":52,"cosmosGeoPoint":220,"geoPoint":222,"contacts":223},"University of Minnesota","55455",{"type":54,"coordinates":221},[205,206],{"lat":206,"lon":205},[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,"countryCode":52,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"The Feinstein Institutes, Northwell Health, Inc.","Manhasset","New York","11030",{"type":54,"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 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University","Cleveland","Ohio","44106",{"type":54,"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":289,"city":269,"state":270,"zip":290,"country":51,"countryCode":52,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"The Cleveland Clinic","NOT_YET_RECRUITING","44195",{"type":54,"coordinates":292},[274,275],{"lat":275,"lon":274},[295],{"name":296,"role":37,"phone":297,"phoneExt":26,"email":298},"Taebin Son","216-444-9508","Sont16@ccf.org",{"facility":300,"status":47,"city":301,"state":302,"zip":303,"country":51,"countryCode":52,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":54,"coordinates":305},[306,307],-75.16362,39.95238,{"lat":307,"lon":306},[310,313],{"name":311,"role":37,"phone":26,"phoneExt":26,"email":312},"Grace Kim","gracekim.lee@pennmedicine.upenn.edu",{"name":314,"role":34,"phone":26,"phoneExt":26,"email":26},"Jorge Marrero, MD,MS",{"facility":316,"status":47,"city":317,"state":318,"zip":319,"country":51,"countryCode":52,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"UT Southwestern Medical Center and Parkland Hospital","Dallas","Texas","75390",{"type":54,"coordinates":321},[322,323],-96.80667,32.78306,{"lat":323,"lon":322},[326,330],{"name":327,"role":37,"phone":328,"phoneExt":26,"email":329},"Sneha Deodhar, MS","214.645.1378","TRACER@UTSouthwestern.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":332,"status":47,"city":333,"state":318,"zip":334,"country":51,"countryCode":52,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Baylor College of Medicine","Houston","77021",{"type":54,"coordinates":336},[337,338],-95.36327,29.76328,{"lat":338,"lon":337},[341,345,347],{"name":342,"role":37,"phone":343,"phoneExt":26,"email":344},"Emad Sorial","713-798-7370","Emad.Sorial@bcm.edu",{"name":26,"role":37,"phone":26,"phoneExt":26,"email":346},"Sara.Fares@bcm.edu",{"name":348,"role":34,"phone":26,"phoneExt":26,"email":26},"Fasiha Kanwal, MD, MSHS",{"facility":350,"status":289,"city":351,"state":352,"zip":353,"country":51,"countryCode":52,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Virginia Commonwealth University","Richmond","Virginia","23219",{"type":54,"coordinates":355},[356,357],-77.46026,37.55376,{"lat":357,"lon":356},[360,364,368],{"name":361,"role":37,"phone":362,"phoneExt":26,"email":363},"Hannah Lee, MD","804-828-4060","Hannah.Lee@vcuhealth.org",{"name":365,"role":37,"phone":366,"phoneExt":26,"email":367},"Hannah Cook","804-628-9312","Hannah.Cook1@vcuhealth.org",{"name":361,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":370,"investigatorTitle":371,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amit Singal","Professor",[373,376,377,378,380,381,383],{"name":374,"class":375},"National Cancer Institute (NCI)","NIH",{"name":300,"class":6},{"name":168,"class":6},{"name":379,"class":6},"Dana-Farber Cancer Institute",{"name":332,"class":6},{"name":382,"class":6},"Fred Hutchinson Cancer Center",{"name":288,"class":6},"100522562","phase-4-national-liver-cancer-screening-trial-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":395,"type":396},5500,"ESTIMATED","INTERVENTIONAL",[399],"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.",[402,403,404,405],"Carcinoma, Hepatocellular","Liver Cancer","Liver Cirrhosis","Hepatitis B",[407,23,408],"Hepatocellular carcinoma surveillance","Alpha Fetoprotein","2026-08-10",{"date":411,"type":412},"2026-08-12","ACTUAL",{"date":414,"type":412},"2023-12-26",{"date":416,"type":396},"2034-12-31",{"name":5,"class":6},19]