Health Condition 1: C220- Liver cell carcinoma
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Prof Mohamed Rela
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients diagnosed with HCC who have undergone curative resection or liver transplantation, capable of giving informed consent, and available for regular follow-up
Exclusion criteria
Exclusion criteria: Patients with other primary malignancies, those undergoing palliative treatment, or with significant comorbid conditions that could interfere with the study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine the Diagnostic Accuracy of cfDNA: Assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cfDNA for the early detection of HCC recurrence. To Compare the Diagnostic Performance of cfDNA with AFP and PIVKA-II: Compare the sensitivity, specificity, PPV, and NPV of cfDNA against those of AFP and PIVKA-II in the same cohort of patients to identify which biomarker or combination of biomarkers provides the highest diagnostic accuracy for HCC recurrence. Timepoint: 3 months, 6 months, 9 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To Evaluate the Time to Detection of HCC Recurrence: Compare the time to detection of HCC recurrence among the biomarkers studied (cfDNA, AFP, PIVKA-II) and determine if cfDNA can detect recurrence earlier than traditional biomarkers and imaging studies. 2. To Explore the Cost-effectiveness of cfDNA Monitoring: Conduct a preliminary analysis of the cost-effectiveness of incorporating cfDNA into the standard post-treatment surveillance protocol for HCC patients, considering the potential impact on patient management and outcomes. 3. To Examine the Impact of Treatment Modalities on Biomarker Efficacy: Assess whether the type of initial treatment (resection surgery vs. liver transplantation) influences the diagnostic accuracy of cfDNA and traditional biomarkers in detecting HCC recurrence. Timepoint: 3 months, 6 months, 9 months, 12 months | — |
Countries
India
Contacts
Public ContactAshwin Rammohan
Dr. Rela Institute and Medical Centre
Outcome results
None listed