Non-Cirrhotic Portal HypertensionNCT06500403
Non-invasive Tools for PSVD Diagnosis
An observational study of Non-Cirrhotic Portal Hypertension and Porto-Sinusoidal Vascular Diseases, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases
- What is being tested?
- liver and stiffness measurement
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 31 Dec 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.
Who may be able to join
- Received platinum chemotherapy for organ tumors;
- Ages 18-80;
- sign the informed consent voluntarily.
Who cannot join
- Liver pathology suggested cirrhosis;
- Underwent liver transplantation;
- Combined with hepatocellular carcinoma exceeding Milan criteria;
- Complicated with severe heart, kidney, or lung failure;
- Pregnant or lactating women;
- Data is seriously missing;
- Patients were judged not suitable for participation in this study by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital, Southern Medical Uiversity
Guangzhou, Guangdong, 510080
Xiaofeng Zhang, +8618565552050, 1282614092@qq.com
About this study
Official title: Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
Read the detailed description
PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
- Being tested
- liver and stiffness measurement
- Medical subject headings
- Idiopathic Noncirrhotic Portal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver and stiffness measurementDiagnostic test
liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension
| Study group | Role | What they receive |
|---|---|---|
| Patients who have received platinum-based chemotherapy for organ tumors | Not described Receives: Diagnostic Test: liver and stiffness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Searching for valid non-invasive tools for the diagnosis of PSVD
The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively
Measured: 2 years
Secondary outcomes (4)
Patients developed portal-hypertension-related complications
clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.
Measured: 3 years
Patients died
All-cause death
Measured: 3 years
Patients underwent liver transplantation
Patients underwent liver transplantation during follow up
Measured: 3 years
Patients reached the final follow-up time
Patients had accepted 3-year follow up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start28 Feb 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cirrhotic Portal HypertensionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Zhang, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500403
- Sponsor's protocol ID
- NFEC-2023-566
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06500403
- Acronym / sponsor ID
- NFEC-2023-566
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Jul 2024 (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.
Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
Detailed description
PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have received platinum-based chemotherapy for organ tumors | – | Diagnostic Test: liver and stiffness measurement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.
Key inclusion criteria (3 listed)
- Received platinum chemotherapy for organ tumors;
- Ages 18-80;
- sign the informed consent voluntarily.
Key exclusion criteria (7 listed)
- Liver pathology suggested cirrhosis;
- Underwent liver transplantation;
- Combined with hepatocellular carcinoma exceeding Milan criteria;
- Complicated with severe heart, kidney, or lung failure;
- Pregnant or lactating women;
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 |
|---|---|---|
| liver and stiffness measurementliver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension | Diagnostic test | Patients who have received platinum-based chemotherapy for organ tumors |
Primary outcome
Searching for valid non-invasive tools for the diagnosis of PSVD
Time frame: 2 years
The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively
4 secondary outcomes
Patients developed portal-hypertension-related complications
Time frame: 3 years
Patients died
Time frame: 3 years
Patients underwent liver transplantation
Time frame: 3 years
Patients reached the final follow-up time
Time frame: 3 years
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 15 Jul 2024.
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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.
Xiaofeng Zhang principal investigator
Nanfang Hospital, Southern Medical 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 Non-Cirrhotic Portal Hypertension and Porto-Sinusoidal Vascular Diseases, run by Nanfang Hospital, Southern Medical 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 3 inclusion and 7 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 15 Jul 2024. 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?
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 Xiaofeng Zhang (+8618565552050, 1282614092@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Searching for valid non-invasive tools for the diagnosis of PSVD (time frame: 2 years). 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 15 Jul 2024.