[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513871":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":47,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":84,"collaborators":86,"id":98,"slug":33,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":33,"enrollmentInfo":107,"targetDuration":33,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":68,"whyStopped":33,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Manchester University NHS Foundation Trust","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of hepatocellular carcinoma diagnosis","Incidence recorded as number of cases per study cohort","2 years",{"measure":14,"description":15,"timeFrame":12},"Stage of hepatocellular carcinoma at diagnosis","Barcelona Clinic Liver Cancer (BCLC) stage 0-D",[17,20,23,26,29],{"measure":18,"description":19,"timeFrame":12},"Rates of false positives for each combination of diagnostic tests","Count (%) of True\u002FFalse positives for each test (against magnetic resonance imaging (MRI) \u002F computerised tomography (CT)) will be reported.\n\nResults from different tests (and their (meaningful) combination) will be tabulated against each other:\n\n* Alpha-fetoprotein (AFP) vs GAAD\n* Ultrasound scan (USS) vs GAAD\n* AFP+ USS vs GAAD\n* AFP+USS vs GAAD +USS\n* AFP\u002FGAAD\u002FUSS\u002FAFP+USS\u002FGAAD+USS vs MRI\u002FCT for those who proceed to confirmatory imaging.",{"measure":21,"description":22,"timeFrame":12},"Rates of curative treatment","Rates of curative treatment being offered (%) will be recorded on an intention to treat (ITT) basis from Multi-Disciplinary Team (MDT) meeting outcomes.",{"measure":24,"description":25,"timeFrame":12},"Rates of adherence","• Attendance rates for biannual surveillance appointments (%), within predefined tolerance of 5-9 months post previous appointment.",{"measure":27,"description":28,"timeFrame":12},"Rates of discontinuation","• Count (%) of surveillance discontinuation, defined as no visit \\>12 months.",{"measure":30,"description":31,"timeFrame":32},"Survival rates","Long-term follow up data will be collected to determine rates of survival following HCC diagnosis at 1-year, 3-years and 5-years.","7 years",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Patients with liver cirrhosis eligible for HCC Surveillance","EXPERIMENTAL","Real-world HCC surveillance cohort will be exposed to Elecsys® GAAD in parallel with standard of care tests.",[46],"Diagnostic Test: Elecsys® GAAD",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":33},"DIAGNOSTIC_TEST","Elecsys® GAAD","Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly early stage (sensitivity 78.9%), with 91.4% specificity for both early and all stages, out-performing current standard of care (Chan et al. 2021). Elecsys® GAAD may be integrated into current surveillance practice to increase early-stage HCC detection rate, reduce unnecessary onward investigations and patient anxiety.",[42],[54],{"name":55,"affiliation":5,"role":56},"Varinder Athwal, MRCP PhD","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":33,"email":62},"Varinder Athwal, PhD","CONTACT","0300 3309444","varinder.athwal@mft.nhs.uk",{"name":64,"role":60,"phone":61,"phoneExt":33,"email":65},"Christopher Mysko, MClinEd MRCP","christopher.mysko@mft.nhs.uk",[67],{"facility":5,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Manchester","Greater Manchester","M13 9WL","United Kingdom","UK",{"type":75,"coordinates":76},"Point",[77,78],-2.23743,53.48095,{"lat":78,"lon":77},[81,83],{"name":64,"role":60,"phone":82,"phoneExt":33,"email":65},"07848471145",{"name":55,"role":56,"phone":33,"phoneExt":33,"email":33},{"type":85,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[87,90,93,96],{"name":88,"class":89},"University of Manchester","OTHER",{"name":91,"class":92},"Roche Pharma AG","INDUSTRY",{"name":94,"class":95},"Unity Insights","UNKNOWN",{"name":97,"class":89},"Imperial College London","100513871",false,"NCT05971108","Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC","Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma","REVISE-HCC","Inclusion Criteria:\n\n• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance\n\nExclusion Criteria:\n\n* Pregnancy\u002Fbreast-feeding.\n* Patients who do not have liver cirrhosis\n* Patients who already have hepatocellular carcinoma\n* Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.","ALL","18 Years",{"count":108,"type":109},600,"ESTIMATED","INTERVENTIONAL",[35],"Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death.\n\nThe goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis.\n\nThe main questions it aims to answer are:\n\n* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC?\n* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations?\n* Does the new surveillance pathway improve adherence?\n\nResearchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.",[114,115],"Liver Cirrhosis","Hepatocellular Carcinoma",[117,118,119,120,121],"GAAD","hepatocellular carcinoma","cirrhosis","health inequalities","surveillance","2025-09-23",{"date":124,"type":125},"2025-09-24","ACTUAL",{"date":127,"type":125},"2024-01-08",{"date":129,"type":109},"2030-07-31",{"name":5,"class":6},1]