NCT06960954Recruiting
PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 116 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 15 Jan 2025
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Tanta University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06960954
What you commit to
- Study type: Observational
- Planned participants: 116
- From 15 Jan 2025 to the primary completion date, 15 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior locoregional therapy or liver transplantation.
Other illness
- Patients with renal insufficiency.
- Patients with other malignancies.
Other
- Patients on vitamin K, vitamin K antagonists or antibiotics.
- Patients with cholestasis.
- Unwilling to participate in our study.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospitals Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.