Non-invasive Tools for PSVD Diagnosis

NCT06500403 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2024-02-28

Last updated

2024-07-15

Condition(s) studied

Non-Cirrhotic Portal HypertensionPorto-Sinusoidal Vascular Diseases

Investigational drug(s) / intervention(s)

liver and stiffness measurement

liver and stiffness measurement: liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Received platinum chemotherapy for organ tumors; 2. Ages 18-80; 3. sign the informed consent voluntarily. Exclusion Criteria: 1. Liver pathology suggested cirrhosis; 2. Underwent liver transplantation; 3. Combined with hepatocellular carcinoma exceeding Milan criteria; 4. Complicated with severe heart, kidney, or lung failure; 5. Pregnant or lactating women; 6. Data is seriously missing; 7. Patients were judged not suitable for participation in this study by the researchers.

Primary outcome measure(s)

Searching for valid non-invasive tools for the diagnosis of PSVD — 2 years
The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively

Trial sites (1)

Facility	City	Region	Status
Nanfang hospital, Southern Medical Uiversity	Guangzhou	Guangdong	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06500403 on ClinicalTrials.gov ↗ ← All trials in China