Neutrophil Extracellular Trap FormationNCT05040347
Neutrophil Extracellular Traps as a Biomarker to Predict Portal Vein Tumor Thrombosis in Patients With Hepatocellular Carcinoma
An observational study of Neutrophil Extracellular Trap Formation and Portal Vein Tumor Thrombosis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neutrophil Extracellular Trap Formation, Portal Vein Tumor Thrombosis
- What is being tested?
- test NETs markers
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma.
Who may be able to join
- （1) Clinical diagnosis of HCC with liver cirhosis (2) Clinical diagnosis of portal vein tumor thrombosis
Who cannot join
- secondary liver malignancy (2)hematologic diseases (3) Bud-Chiah syndrome (4) incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making.
Read the detailed description
Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma. NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a statistical difference between the two groups, and regression analysis was performed between NETs markers and tissue factor and anti-β2 glycoprotein I to investigate whether there was a correlation. This study without any intervention measures, will not cause harm.
- Being tested
- test NETs markers
- Keywords
- Neutrophil Extracellular Trap, Portal Vein Tumor Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test NETs markersOther
NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
| Study group | Role | What they receive |
|---|---|---|
| PVTT group | The diagnosis of portal vein tumor thrombosis was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist. Receives: Other: test NETs markers | |
| HCC group | The diagnosis of HCC was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist. Receives: Other: test NETs markers | |
| control group | The presence of PVTT or HCC was confirmed by medical record review and all the recorded events were confirmed by a radiologist using imaging studies, ultrasound, contrast-enhanced, or MR. Receives: Other: test NETs markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of NETs markers and anti-β2 glycoprotein I
NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start18 Aug 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutrophil Extracellular Trap FormationStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Cohort
- Time perspective
- Other
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040347
- Sponsor's protocol ID
- QYFYWZLL26511
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Extracellular Traps as a Biomarker to Predict Portal Vein Tumor Thrombosis in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05040347
- Acronym / sponsor ID
- QYFYWZLL26511
- Keywords
- Neutrophil Extracellular Trap, Portal Vein Tumor Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Sep 2021 (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 aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making.
Detailed description
Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma. NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. T-test was performed to analyze whether there was a statistical difference between the two groups, and regression analysis was performed between NETs markers and tissue factor and anti-β2 glycoprotein I to investigate whether there was a correlation. This study without any intervention measures, will not cause harm.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVTT group | – | Other: test NETs markersThe diagnosis of portal vein tumor thrombosis was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist. |
| HCC group | – | Other: test NETs markersThe diagnosis of HCC was confirmed by clinical correlation using histologic features taken from liver biopsy as determined by a pathologist,and findings from image studies including ultrasound, computed tomography, and MRI, verified by a radiologist. |
| control group | – | Other: test NETs markersThe presence of PVTT or HCC was confirmed by medical record review and all the recorded events were confirmed by a radiologist using imaging studies, ultrasound, contrast-enhanced, or MR. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-six patients with patients treated at the Affiliated Hospital of Qingdao University (China) from September 2020 to January 2021 were recruited for this study, including 14 patients with portal vein tumor thrombosis, 28 patients without portal vein tumor thrombosis and 44 patients without hepatocellular carcinoma.
Key inclusion criteria (1 listed)
- （1) Clinical diagnosis of HCC with liver cirhosis (2) Clinical diagnosis of portal vein tumor thrombosis
Key exclusion criteria (1 listed)
- secondary liver malignancy (2)hematologic diseases (3) Bud-Chiah syndrome (4) incomplete data
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 |
|---|---|---|
| test NETs markersNETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits. | Other | HCC group, PVTT group, control group |
Primary outcome
Concentration of NETs markers and anti-β2 glycoprotein I
Time frame: 1 year.
NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neutrophil Extracellular Trap Formation and Portal Vein Tumor Thrombosis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Sep 2021. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of NETs markers and anti-β2 glycoprotein I (time frame: 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 10 Sep 2021.