Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
The 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC Patients Treated With TACE | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between blood-based biomarkers and early radiological response | 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). | From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Response Assessment via mRECIST. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) "Bežanijska kosa"
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marko Stojanović, Medical Doctor | Contact | +381601435353 | marko.stojanovic@med.bg.ac.rs |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Bežanijska kosa | Belgrade | Serbia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood (serum and plasma)
| 4-8 weeks after each TACE procedure. |
| Changes in Tumor Marker Levels (AFP and PIVKA-II). | 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. | Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure). |
| Assessment of Liver Function Post-TACE. | 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). | From baseline up to 8 weeks after the final TACE procedure. |
| Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress). | 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). | From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure). |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |