Non-invasive Tools for PSVD Diagnosis | NCT06500403

Studies
Non-invasive Tools for PSVD Diagnosis

NCT06500403

Sponsor

Nanfang Hospital, Southern Medical University

Status

Recruiting

Last Update Posted

Jul 15, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Non-Cirrhotic Portal Hypertension
Porto-Sinusoidal Vascular Diseases

Interventions

liver and stiffness measurement

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Jul 8, 2024

First Posted Date

Jul 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2024

Last Update Posted Date

Jul 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who have received platinum-based chemotherapy for organ tumors			Diagnostic Test: liver and stiffness measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patients developed portal-hypertension-related complications	clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.	3 years
Patients died	All-cause death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaofeng Zhang	Contact	+8618565552050		1282614092@qq.com

Overall Officials

Name	Affiliation	Role
Xiaofeng Zhang	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang hospital, Southern Medical Uiversity	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D000094724	Idiopathic Noncirrhotic Portal Hypertension

Ancestor Terms

ID	Term
D006975	Hypertension, Portal
D008107	Liver Diseases
D004066	Digestive System Diseases

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