Hepato Cellular Carcinoma (HCC)NCT06960954
PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
An observational study of Hepato Cellular Carcinoma (HCC) and Portal Vein Tumour Thrombosis, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC), Portal Vein Tumour Thrombosis
- What is being tested?
- Prothrombin induced by vitamin K absence II (PIVKA-II)
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cross-sectional study will be carried out on 116 patients attending the Tanta Tropical Medicine Outpatient Clinic, Faculty of Medicine. The start of the research will be in January 2025 to December 2025 or until the collection of the cases.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, head of department, 00201117109990, dina.ziada@med.tanta.edu.eg
Rania M Elkafoury, MD
About this study
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.
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).
- Being tested
- Prothrombin induced by vitamin K absence II (PIVKA-II)
- Keywords
- PIVKA-II, Portal vein tumor thrombosis, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin induced by vitamin K absence II (PIVKA-II)Diagnostic test
Serum PIVKA-II level will be measured in HCC patients with and without PVTT.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients with PVTT. | 58 HCC patients with PVTT. Receives: Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II) | |
| HCC Patients without PVTT. | 58 HCC Patients without PVTT. Receives: Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIVKA-II serum level for prediction of PVTT in HCC patients.
PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start15 Jan 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Rania M Elkafoury, MD, Study director, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960954
- Sponsor's protocol ID
- 36264PR1127/3/25
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06960954
- Acronym / sponsor ID
- 36264PR1127/3/25
- Keywords
- PIVKA-II, Portal vein tumor thrombosis, Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC patients with PVTT. | – | Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)58 HCC patients with PVTT. |
| HCC Patients without PVTT. | – | Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)58 HCC Patients without PVTT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study will be carried out on 116 patients attending the Tanta Tropical Medicine Outpatient Clinic, Faculty of Medicine. The start of the research will be in January 2025 to December 2025 or until the collection of the cases.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prothrombin induced by vitamin K absence II (PIVKA-II)Serum PIVKA-II level will be measured in HCC patients with and without PVTT. | Diagnostic test | HCC Patients without PVTT., HCC patients with PVTT. |
Primary outcome
PIVKA-II serum level for prediction of PVTT in HCC patients.
Time frame: through study completion, an average of 1 year
PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rania M Elkafoury, MD study director
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato Cellular Carcinoma (HCC) and Portal Vein Tumour Thrombosis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIVKA-II serum level for prediction of PVTT in HCC patients. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.