[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522562":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":358,"collaborators":361,"id":372,"slug":373,"hasResults":374,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":374,"sex":379,"minAge":380,"maxAge":381,"enrollmentInfo":382,"targetDuration":26,"studyType":385,"phases":386,"briefSummary":388,"conditions":389,"keywords":394,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":406},{"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",[45,63,82,101,116,135,151,167,183,198,218,233,249,268,288,304,319,337],{"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","916-474-6221","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},[209,213,217],{"name":210,"role":37,"phone":211,"phoneExt":26,"email":212},"Jose Debes, MD","952-737-9762","debes003@umn.edu",{"name":214,"role":37,"phone":215,"phoneExt":26,"email":216},"Daniel Akah","9527379762","Dakah@bermancenter.org",{"name":210,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":219,"status":47,"city":200,"state":201,"zip":220,"country":51,"countryCode":52,"cosmosGeoPoint":221,"geoPoint":223,"contacts":224},"University of Minnesota","55455",{"type":54,"coordinates":222},[205,206],{"lat":206,"lon":205},[225,229,232],{"name":226,"role":37,"phone":227,"phoneExt":26,"email":228},"Elizabeth Aby, MD","612-625-8999","abyxx002@umn.edu",{"name":230,"role":37,"phone":26,"phoneExt":26,"email":231},"Erin Wesley","wesle091@umn.edu",{"name":226,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":234,"status":47,"city":235,"state":236,"zip":237,"country":51,"countryCode":52,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"The Feinstein Institutes, Northwell Health, Inc.","Manhasset","New York","11030",{"type":54,"coordinates":239},[240,241],-73.69957,40.79788,{"lat":241,"lon":240},[244,247],{"name":245,"role":37,"phone":26,"phoneExt":26,"email":246},"Dibnain Nanda","dnanda1@northwell.edu",{"name":248,"role":34,"phone":26,"phoneExt":26,"email":26},"Sanjaya Satapathy, MBBS, MS",{"facility":250,"status":47,"city":251,"state":252,"zip":253,"country":51,"countryCode":52,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":54,"coordinates":255},[256,257],-79.05584,35.9132,{"lat":257,"lon":256},[260,264,267],{"name":261,"role":37,"phone":262,"phoneExt":26,"email":263},"Andrew Moon, MD","919-843-5936","Andrew.Moon@unchealth.unc.edu",{"name":265,"role":37,"phone":262,"phoneExt":26,"email":266},"Bhagyashree Behera","BB_Behera@med.unc.edu",{"name":261,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":269,"status":47,"city":270,"state":271,"zip":272,"country":51,"countryCode":52,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Case Western Reserve University","Cleveland","Ohio","44106",{"type":54,"coordinates":274},[275,276],-81.69541,41.4995,{"lat":276,"lon":275},[279,283,287],{"name":280,"role":37,"phone":281,"phoneExt":26,"email":282},"Pierre Gholam, MD","216-286-6757","pierre.gholam@case.edu",{"name":284,"role":37,"phone":285,"phoneExt":26,"email":286},"Paul Harris","216.983.5144","Paul.Harris2@UHhospitals.org",{"name":280,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":289,"status":47,"city":290,"state":291,"zip":292,"country":51,"countryCode":52,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":54,"coordinates":294},[295,296],-75.16362,39.95238,{"lat":296,"lon":295},[299,302],{"name":300,"role":37,"phone":26,"phoneExt":26,"email":301},"Grace Kim","gracekim.lee@pennmedicine.upenn.edu",{"name":303,"role":34,"phone":26,"phoneExt":26,"email":26},"Jorge Marrero, MD,MS",{"facility":305,"status":47,"city":306,"state":307,"zip":308,"country":51,"countryCode":52,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"UT Southwestern Medical Center and Parkland Hospital","Dallas","Texas","75390",{"type":54,"coordinates":310},[311,312],-96.80667,32.78306,{"lat":312,"lon":311},[315,318],{"name":41,"role":37,"phone":316,"phoneExt":26,"email":317},"214-645-1378","TRACER@UTSouthwestern.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":320,"status":47,"city":321,"state":307,"zip":322,"country":51,"countryCode":52,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"Baylor College of Medicine","Houston","77021",{"type":54,"coordinates":324},[325,326],-95.36327,29.76328,{"lat":326,"lon":325},[329,333,335],{"name":330,"role":37,"phone":331,"phoneExt":26,"email":332},"Emad Sorial","713-798-7370","Emad.Sorial@bcm.edu",{"name":26,"role":37,"phone":26,"phoneExt":26,"email":334},"Sara.Fares@bcm.edu",{"name":336,"role":34,"phone":26,"phoneExt":26,"email":26},"Fasiha Kanwal, MD, MSHS",{"facility":338,"status":339,"city":340,"state":341,"zip":342,"country":51,"countryCode":52,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Virginia Commonwealth University","NOT_YET_RECRUITING","Richmond","Virginia","23219",{"type":54,"coordinates":344},[345,346],-77.46026,37.55376,{"lat":346,"lon":345},[349,353,357],{"name":350,"role":37,"phone":351,"phoneExt":26,"email":352},"Hannah Lee, MD","804-828-4060","Hannah.Lee@vcuhealth.org",{"name":354,"role":37,"phone":355,"phoneExt":26,"email":356},"Hannah Cook","804-628-9312","Hannah.Cook1@vcuhealth.org",{"name":350,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":359,"investigatorTitle":360,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amit Singal","Professor",[362,365,366,367,369,370],{"name":363,"class":364},"National Cancer Institute (NCI)","NIH",{"name":289,"class":6},{"name":168,"class":6},{"name":368,"class":6},"Dana-Farber Cancer Institute",{"name":320,"class":6},{"name":371,"class":6},"Fred Hutchinson Cancer Center","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":383,"type":384},5500,"ESTIMATED","INTERVENTIONAL",[387],"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.",[390,391,392,393],"Carcinoma, Hepatocellular","Liver Cancer","Liver Cirrhosis","Hepatitis B",[395,23,396],"Hepatocellular carcinoma surveillance","Alpha Fetoprotein","2025-11-25",{"date":399,"type":400},"2025-11-26","ACTUAL",{"date":402,"type":400},"2023-12-26",{"date":404,"type":384},"2034-12-31",{"name":5,"class":6},18]