Evaluating PIVKA-II levels in liver cancer patients with portal vein thrombosis
Official title: Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.
Run by Tanta University · NCT06960954 · Data updated 2026-11-12
This study is trying to see if measuring a specific protein in the blood can help tell if liver cancer patients have a blockage in their portal vein caused by the tumor.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | December 15, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT06960954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years with confirmed hepatocellular carcinoma, regardless of the presence of portal vein tumor thrombosis.
✕Probably not a fit
Patients who have undergone prior locoregional therapy, liver transplantation, or those with other malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the relationship between Prothrombin induced by vitamin K absence II (PIVKA-II) serum levels and the presence of portal vein tumor thrombosis (PVTT) in patients diagnosed with hepatocellular carcinoma (HCC). Researchers will compare PIVKA-II levels in HCC patients who have PVTT against those who do not. Participants will undergo a series of evaluations including clinical examinations, laboratory tests, and imaging studies to determine tumor characteristics and the presence of PVTT. The study seeks to enhance understanding of PIVKA-II as a potential biomarker for PVTT in HCC patients.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for predicting portal vein thrombosis in hepatocellular carcinoma patients, aiding in early diagnosis and treatment.
How similar studies have gone: While the specific approach of using PIVKA-II for this purpose may be novel, similar studies have explored biomarkers in relation to portal vein thrombosis in liver cancer, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tanta University Hospitals
Tanta, Gharbyea, Egypt Recruiting
Study contacts
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Anatomic vs nonanatomic liver resection after conversion therapy for liver cancer
This study tests whether removing more precisely targeted liver tissue (anatomic resection) works better than removing tissue more broadly (nonanatomic) for patients whose unresectable liver cancer became eligible for surgery after PD-1/PD-L1–based therapy.
-
Impact of Anesthesia on Inflammation and NETosis During HCC Ablation
This study tests whether a propofol–fentanyl anesthesia plan with lidocaine during radiofrequency ablation for hepatocellular carcinoma affects inflammation and NETosis in patients with small tumors.
-
Pre-emptive topical indomethacin to prevent sorafenib-related hand-foot syndrome in advanced liver cancer
This trial will test whether applying 1% indomethacin gel to both hands twice daily can reduce hand-foot syndrome in adults with advanced hepatocellular carcinoma starting sorafenib.
-
Becotatug vedotin (MRG003) for previously treated advanced liver cancer with EGFR testing
This study will test whether Becotatug vedotin (MRG003) helps people with advanced hepatocellular carcinoma whose cancer progressed after PD‑1/L1 therapy.
-
TACE or Ablation With Sintilimab and Ipilimumab Before Surgery for Liver Cancer
This study tests whether combining local tumor treatments with immunotherapy before surgery helps people with resectable hepatocellular carcinoma at higher risk of recurrence.
-
Personalized adaptive second-line treatments for advanced liver cancer
This trial tries different personalized second-line treatments to find which work best for people with advanced hepatocellular carcinoma after first-line immunotherapy-based regimens stop working.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.