Prospective Studies on Immunopathogenesis of Liver Fibrosis

NCT04943978 | Unknown DMC

• 1 other identifier: 13-257-101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis. In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. However, the liver is the site of increased occurrence of the components of the innate immune response (NK and NKT cells) and, in contrast to T cells, these T cells, these do not require antigen presentation. Therefore, the present study was designed to determine which cellular components of the (NK, NKT, dendritic cells, macrophages) or the acquired immune response (CD4, CD8) or which network of immune cells is involved in the immunopathogenesis of progressive liver inflammation or the development of liver fibrosis. The aim is to identify lymphocyte populations that exhibit either prognostically favorable or unfavorable characteristics. This should allow conclusions to be drawn for a more targeted and individualized therapy of the respective chronic liver diseases.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (2)

• Liver fibrosis

  Stage of liver fibrosis in histology (Ishak-score (1 - 6))

  Day 0

• Liver Steatosis

  Stage of liver steatosis in histology (NASH activity score (1 - 8))

  Day 0

Secondary Outcomes (1)

• Survival

  After 3 years

Study Arms (1)

Liver disease

Patients with either acute or chronic liver disease

Eligibility Criteria

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

Study Population

Patients with chronic or acute liver disease undergoing surgery.

You may qualify if:

• Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC).
• Patients with elevated liver values undergoing elective abdominal surgery.
• As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease.

You may not qualify if:

• Age under 18

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

Dept. of Surgery, University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy

Central Study Contacts

Jens M. Werner, MD

CONTACT

+49941944; jens.werner@ukr.de

Florian Bitterer, MD

CONTACT

+49941944; florian.bitterer@ukr.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Exp. Surgery

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: February 1, 2014
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2026
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

DE (1)