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Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to evaluate changes in selected biomarkers and their potential connection with early radiological outcomes in adult patients with hepatocellular carcinoma (HCC) who are candidates for Transarterial Chemoembolization (TACE) treatment. The main questions it aims to answer are whether specific biomarkers change in response to TACE treatment and if there is a correlation between these changes and early radiological treatment response as measured by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Participants will undergo standard-of-care TACE as decided by a multidisciplinary team and will provide blood samples at predefined, clinically relevant time points, specifically before the first TACE procedure and during subsequent follow-up cycles on the day of either a new TACE or a control Computed Tomography (CT) scan. Additionally, participants will undergo routine clinical and radiological assessments, including multiphase CT or Magnetic Resonance Imaging (MRI) scans four to eight weeks after the procedure to monitor treatment success, with all data being collected from medical records and standard diagnostic procedures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Diagnosis of hepatocellular carcinoma (HCC) based on LI-RADS CT/MRI v2018 criteria or histopathological verification

• Candidate for TACE as part of standard treatment (BCLC criteria)

• Child-Pugh score ≤ 7 at the time of TACE indication

• ECOG performance status 0 at the time of TACE indication

• Availability of at least one follow-up multiphase CT or MRI scan 4-8 weeks after TACE

Locations
Other Locations
Serbia
KBC Bežanijska kosa
RECRUITING
Belgrade
Contact Information
Primary
Marko Stojanović, Medical Doctor
marko.stojanovic@med.bg.ac.rs
00381601435353
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 15
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Belgrade

This content was sourced from clinicaltrials.gov

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