[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06728293":3,"trial-entities:NCT06728293":142,"trial-summary:NCT06728293":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":48,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":94,"locations":97,"central_contacts":130,"overall_officials":139,"references":140,"see_also_links":141},"NCT06728293","23696","Effect of the HCC Liver-Link Intervention","RECRUITING","2027-01","2026-05","2026-06-05","2025-06-10","Indiana University","OTHER",true,"This study is a pilot, multi-center randomized controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care. The intervention combines: (1) patient education to improve HCC-related disease and treatment knowledge, (2) social needs and substance use screening with referral to social work and community resources, and (3) facilitated access to subspecialty cancer care through a multidisciplinary HCC tumor board.\n\nA total of 40 Black patients with Barcelona Clinic Liver Cancer (BCLC) stage 0, A, or downstaged B disease will be randomized to receive either the HCC Liver-Link intervention or usual care and followed for 6 months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform development of larger interventions to eliminate racial disparities in HCC outcomes.",null,[18,19],"HCC","Racial Disparities",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32},"Liver Link","Support Program",[33],"Liver-Link Arm",[35,39,42,45],{"measure":36,"description":37,"timeFrame":38},"Time to waitlist","Days from study enrollment to liver transplant waitlisting, assessed using OTTR.","Up to 6 months post-enrollment",{"measure":40,"description":41,"timeFrame":38},"Time to resection","Days from study enrollment to surgical resection, assessed using EMR.",{"measure":43,"description":44,"timeFrame":38},"Waitlisting or Resection","Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR",{"measure":46,"description":47,"timeFrame":38},"Time to Death","Days from study enrollment to death, assessed using EMR and OTTR.",[49,53,56,60],{"measure":50,"description":51,"timeFrame":52},"HCC-Related Knowledge","Score on a 10-item internally developed HCC knowledge multiple-choice test.","Baseline and 6 months post-enrollment.",{"measure":54,"description":55,"timeFrame":52},"Medical Mistrust","Score on 7-item Medical Mistrust Index.",{"measure":57,"description":58,"timeFrame":59},"Social Needs and AUD Linkage","Percentage of participants offered services for a social need, achieving improvement in a social need, and without alcohol use in the past 90 days; assessed by patient and social worker reports in REDCap.","Up to 6 months post-enrollment.",{"measure":61,"description":62,"timeFrame":52},"Quality of Life (QOL)","Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool.","ALL","18 Years","75 Years",false,{"inclusion":68,"exclusion":83,"raw_text":93},[69,70,71,72,73,74,75,76,77,78,79,80,81,82],"One Class 5 lesion greater than 5 cm and less than or equal to 8 cm","two or three Class 5 lesions that meeting all of the following","At least one lesion greater than 3cm","Each lesion less than or equal to 5 cm, and","A total diameter of all lesions less than or equal to 8cm","Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.","Between 18-75 years old","Have no more than two visits with an HCC-related provider","Able to read, write, and speak English","Any 1 of the following:","Self-report as Black race (can be multiple races as long as 1 is Black)","Self-report as insured by Medicaid (+\u002F- Medicare)","SVI (Social vulnerability index) \\>= .75","Unmarried",[84,85,86,87,88,89,90,91,92],"Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.","Age over 75","Last transthoracic echocardiogram with EF\\\u003C40% (OK if no prior echo)","BMI over 50","Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented","Prior history of any solid organ transplant","Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)","Patients who have undergone resection or waitlisted","Patients near completion of transplant evaluation, PI to determine utility of intervention.","Inclusion Criteria\n\n• Within UCSF criteria:\n\nCandidates are eligible or a standardized MELD or PELD exception if, before completing locoregional therapy, they have lesions that meet one of the following criteria:\n\n* One Class 5 lesion greater than 5 cm and less than or equal to 8 cm\n* two or three Class 5 lesions that meeting all of the following\n\n  * At least one lesion greater than 3cm\n  * Each lesion less than or equal to 5 cm, and\n  * A total diameter of all lesions less than or equal to 8cm\n* Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.\n* Between 18-75 years old\n* Have no more than two visits with an HCC-related provider\n* Able to read, write, and speak English\n* Any 1 of the following:\n\n  * Self-report as Black race (can be multiple races as long as 1 is Black)\n  * Self-report as insured by Medicaid (+\u002F- Medicare)\n  * SVI (Social vulnerability index) \\>= .75\n  * Unmarried\n\nExclusion Criteria\n\n* Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.\n* Age over 75\n* Last transthoracic echocardiogram with EF\\\u003C40% (OK if no prior echo)\n* BMI over 50\n* Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented\n* Prior history of any solid organ transplant\n* Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)\n* Patients who have undergone resection or waitlisted\n* Patients near completion of transplant evaluation, PI to determine utility of intervention.",[95,96],"ADULT","OLDER_ADULT",[98,116],{"facility":99,"status":7,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":113},"Indiana University School of Medicine","Indianapolis","Indiana","46202","United States",[105,110],{"name":106,"role":107,"phone":108,"email":109},"Anaiya Crowner","CONTACT","(317) 274-0481","acrowner@iu.edu",{"name":111,"role":112},"Lauren Nephew, MD","PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},39.76838,-86.15804,{"facility":117,"status":7,"city":118,"state":119,"zip":120,"country":103,"contacts":121,"geoPoint":127},"Johns Hopkins University","Baltimore","Maryland","21218",[122,126],{"name":123,"role":107,"phone":124,"email":125},"Aly T Strauss, MD","410-614-1982","astraus6@jhmi.edu",{"name":123,"role":112},{"lat":128,"lon":129},39.29038,-76.61219,[131,135],{"name":132,"role":107,"phone":133,"email":134},"Savannah Yarnelle","(317) 278-6424","samussel@iu.edu",{"name":136,"role":107,"phone":137,"email":138},"Regina Weber","(317) 278-3584","reginaw@iu.edu",[],[],[],{"nct_id":4,"conditions":143,"biomarkers":145},[144],"Hepatocellular Carcinoma",[],{"nct_id":4,"found":14,"summary":147,"prompt_version":157},{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is a pilot study that will randomly assign 40 Black patients to either receive the HCC Liver-Link intervention or usual care.","completed","HCC Liver-Link Intervention for Liver Cancer","This study is testing a support program called HCC Liver-Link for Black patients with hepatocellular carcinoma (HCC), a type of liver cancer. The program aims to reduce differences in care by offering patient education about HCC, screening for social needs and substance use with referrals to help, and easier access to specialized cancer care. We are looking for 40 Black patients, aged 18 to 75, who meet specific criteria for their liver cancer. The study will compare patients who receive the HCC Liver-Link program to those who receive usual care. We will follow participants for up to 6 months to see if the program helps them get on the liver transplant waitlist or have surgery sooner.","Participants will be followed for up to 6 months after enrollment or until liver transplant waitlisting.",116,"Participants will be followed for 6 months or until they are waitlisted for a liver transplant.","Not stated in the trial record.",[],"v2"]