Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 7:10 PM
Study NCT ID:
NCT07414433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (serum and plasma)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between blood-based biomarkers and early radiological response', 'timeFrame': 'From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.', 'description': 'Evaluation of changes in selected biomarkers (including AFP and PIVKA-II) and their potential association with early radiological outcomes following TACE, assessed using mRECIST criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).'}], 'secondaryOutcomes': [{'measure': 'Radiological Response Assessment via mRECIST.', 'timeFrame': '4-8 weeks after each TACE procedure.', 'description': 'Tumor response will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), a categorical scale used to assess viable tumor based on arterial enhancement on CT or MRI scans. Scale Information: Scale Type: Categorical Minimum Value: Complete Response (CR) - best outcome Maximum Value: Progressive Disease (PD) - worst outcome Directionality: Higher category represents a worse outcome Categories: Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) Outcome Reporting: The percentage of patients achieving each response category (CR, PR, SD, PD) will be reported.'}, {'measure': 'Changes in Tumor Marker Levels (AFP and PIVKA-II).', 'timeFrame': 'Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).', 'description': 'Measurement of the change in serum levels of Alpha-fetoprotein (AFP) and Protein Induced by Vitamin K Absence (PIVKA-II from baseline to follow-up points.'}, {'measure': 'Assessment of Liver Function Post-TACE.', 'timeFrame': 'From baseline up to 8 weeks after the final TACE procedure.', 'description': 'Liver function will be monitored using the Child-Pugh Liver Function Score, which evaluates hepatic reserve based on five clinical and laboratory parameters (bilirubin, albumin, INR/prothrombin time, ascites, and hepatic encephalopathy). The score is calculated at baseline and during follow-up assessments to evaluate potential liver function deterioration after TACE. Scale Information: Full Scale Name: Child-Pugh Liver Function Score Scale Type: Ordinal numeric scale with clinical class categories Minimum Value: 5 points - best liver function (Child-Pugh Class A) Maximum Value: 15 points - worst liver function (Child-Pugh Class C) Directionality: Higher scores represent a worse clinical outcome Score Ranges / Classes: 5-6 points: Child-Pugh A (well-compensated liver disease) 7-9 points: Child-Pugh B (significant functional impairment) 10-15 points: Child-Pugh C (severe hepatic dysfunction).'}, {'measure': 'Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress).', 'timeFrame': 'From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).', 'description': 'An exploratory evaluation of serum samples to identify changes in protein profiles (proteomics), circulating microRNA (miRNA) signatures, and markers of oxidative stress (e.g., Malondialdehyde, Superoxide Dismutase) as potential predictors or indicators of radiological response to Drug-eluting Bead Trans arterial Chemoembolization (DEB-TACE).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'TACE', 'Biomarkers', 'mRECIST', 'Drug-Eluting Beads'], 'conditions': ['Hepatocellular Carcinoma (HCC)', 'Liver Neoplasms']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective observational study is to validate the clinical utility of specific blood-based biomarkers for predicting and monitoring treatment response in patients with hepatocellular carcinoma (HCC) undergoing Transarterial Chemoembolization (TACE).\n\nThe study aims to determine if longitudinal changes in these biomarkers can reliably correlate with early radiological treatment response, as measured by Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants will receive standard-of-care TACE treatment and will provide blood samples at baseline and during subsequent clinical follow-up cycles. Biomarker levels will be compared against routine multiphase computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans performed four to eight weeks post-procedure to establish their accuracy as predictive tools for clinical success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) "Bežanijska kosa"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of hepatocellular carcinoma (HCC) based on LI-RADS CT/MRI v2018 criteria or histopathological verification\n* Candidate for TACE as part of standard treatment (BCLC criteria)\n* Child-Pugh score ≤ 7 at the time of TACE indication\n* ECOG performance status 0 at the time of TACE indication\n* Availability of at least one follow-up multiphase CT or MRI scan 4-8 weeks after TACE\n\nExclusion Criteria:\n\n* Child-Pugh score ≥8 at the time of TACE indication\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 0 at the time of TACE indication.\n* Presence of extrahepatic dissemination and/or macrovascular invasion\n* Technically unfeasible TACE (e.g., inability to identify feeder artery)\n* Severe uncorrectable coagulopathy or cytopenia\n* Severe allergy or contraindication to iodine contrast agent or drugs used during TACE\n* Pregnancy or breastfeeding\n* Inability to provide signed informed consent'}, 'identificationModule': {'nctId': 'NCT07414433', 'acronym': 'BLOOD-TACE-M', 'briefTitle': 'Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '6249_main_study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC Patients Treated With TACE', 'description': 'Patients with hepatocellular carcinoma (HCC) who are candidates for transarterial chemoembolization (TACE) as part of their standard clinical care. This group includes adult patients with preserved liver function (Child-Pugh ≤ 7) and good performance status Eastern Cooperative Oncology Group (ECOG) 0.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belgrade', 'country': 'Serbia', 'contacts': [{'name': 'Jovana Popović, Medical Doctor', 'role': 'CONTACT', 'email': 'jovana.lalatovic@gmail.com', 'phone': '+38162214194'}], 'facility': 'KBC Bežanijska kosa', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Marko Stojanović, Medical Doctor', 'role': 'CONTACT', 'email': 'marko.stojanovic@med.bg.ac.rs', 'phone': '+381601435353'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Pharmacology, Clinical Pharmacology and Toxicology', 'investigatorFullName': 'Marko Stojanovic', 'investigatorAffiliation': 'University of Belgrade'}}}}