Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets

NCT03979417 | Completed

• 1 other identifier: 2018-069
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (\> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.

Conditions

Hepatopathy; Fibrosis

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (1)

• Identification of biomarkers of liver fibrosis

  Frequency of cell receptors (CD4, CD8, NK, MAIT, etc.) in whole blood and liver (measured by FACS). A comparison will be made in each of the 3 groups (F0-F1, F2-F3, F4) and between the three groups.

  Baseline

Secondary Outcomes (2)

• Transcription factors

  Baseline

• Evaluation of anti-fibrotic properties of biomarkers

  Baseline

Study Arms (3)

Liver fibrosis F0-F1

Blood draw and liver resection at the liver surgery

Other: Blood draw and liver resection

Liver fibrosis F2-F3

Blood draw and liver resection at the liver surgery

Other: Blood draw and liver resection

Liver Fibrosis F4

Blood draw and liver resection at the liver surgery

Other: Blood draw and liver resection

Interventions

Blood draw and liver resection OTHER

The samples are transferred to the research unit for immunological studies.

Liver Fibrosis F4; Liver fibrosis F0-F1; Liver fibrosis F2-F3

Eligibility Criteria

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

Study Population

Patients with primary hepatopathies or liver metastasis with indication for liver resection.

You may qualify if:

• Patients \> 18 years
• Patients with primary liver disease or liver metastases
• Patients undergoing liver resection

You may not qualify if:

• Presence of Human Immunodeficiency Virus (HIV) infection
• Presence of Human T Leukemia Virus (HTLV) infection
• Taking immunosuppressive drugs in the 6 months prior to surgery
• A person deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (2)

Pitie-Salpetriere Hospital

Paris, 75013, France

Location

Cochin Hospital

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cell (PBMC), Liver samples

MeSH Terms

Conditions

Digestive System Diseases; Fibrosis

Interventions

Blood Specimen Collection; Hepatectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Surgical Procedures

Study Design

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

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: June 7, 2019
• Study Start: September 30, 2019
• Primary Completion: September 1, 2022
• Study Completion: October 26, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)