Evaluating PIVKA-II levels in liver cancer patients with portal vein thrombosis
Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.
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 |
|---|---|
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbyea) |
| Trial ID | NCT06960954 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with confirmed hepatocellular carcinoma, regardless of the presence of portal vein tumor thrombosis.
Not a fit: Patients who have undergone prior locoregional therapy, liver transplantation, or those with other malignancies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, Gharbyea
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (Recruiting)
Study contacts
- Study coordinator: Rania M Elkafoury, MD
- Email: rania.elkafoury@med.tanta.edu.eg
- Phone: +201004672358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.