Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Hepato Cellular Carcinoma (HCC) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment116 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, Gharbyea)
StatusRecruiting
StartedJanuary 15, 2025
Main results expectedDecember 15, 2025
Study endsDecember 31, 2025
Registry record updatedMay 7, 2025
Trial IDNCT06960954 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.