Non-invasive Tools for PSVD Diagnosis

NCT06500403 | Recruiting

• 1 other identifier: NFEC-2023-566
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Cirrhotic Portal Hypertension; Porto-Sinusoidal Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (4)

• Patients developed portal-hypertension-related complications

  3 years

• Patients died

  3 years

• Patients underwent liver transplantation

  3 years

• Patients reached the final follow-up time

  3 years

Study Arms (1)

Patients who have received platinum-based chemotherapy for organ tumors

Diagnostic Test: liver and stiffness measurement

Interventions

liver and stiffness measurement DIAGNOSTIC_TEST

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

Patients who have received platinum-based chemotherapy for organ tumors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.

You may qualify if:

• Received platinum chemotherapy for organ tumors;
• Ages 18-80;
• sign the informed consent voluntarily.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital, Southern Medical Uiversity

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Noncirrhotic Portal Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Portal; Liver Diseases; Digestive System Diseases

Study Officials

• Xiaofeng Zhang

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Zhang

CONTACT

+8618565552050; 1282614092@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

CN (1)