NCT06960954 PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
| NCT ID | NCT06960954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Hepato Cellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 116 participants in total. It began in 2025-01-15 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients. Researchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT. Participants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).
Eligibility Criteria
Inclusion Criteria: * Male or female patients older than 18 years. * Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy). Exclusion Criteria: * Prior locoregional therapy or liver transplantation. * Patients on vitamin K, vitamin K antagonists or antibiotics. * Patients with cholestasis. * Patients with renal insufficiency. * Patients with other malignancies. * Unwilling to participate in our study.
Contact & Investigator
Rania M Elkafoury, MD
STUDY DIRECTOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Frequently Asked Questions
Who can join the NCT06960954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepato Cellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960954 currently recruiting?
Yes, NCT06960954 is actively recruiting participants. Contact the research team at rania.elkafoury@med.tanta.edu.eg for enrollment information.
Where is the NCT06960954 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06960954 clinical trial?
NCT06960954 is sponsored by Tanta University. The principal investigator is Rania M Elkafoury, MD at Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University. The trial plans to enroll 116 participants.