Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients
NCT ID: NCT06047093
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-03-08
2028-03-08
Brief Summary
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The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection.
The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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HBsAg <100 IU/ml
Patients chronically mono-infected with HBV, whose HBsAg is less than 100 IU/ml (patients treated or not with NA)
Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
HBsAg between 100 and 3000 IU/ml
Patients chronically mono-infected with HBV, with HBsAg levels \>100 and \<3000 IU/ml (patients treated or not with NA).
Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
HBsAg ≥ 3000 IU/ml
Patients chronically mono-infected with HBV, with HBsAg levels ≥ 3000 IU/ml (patients treated or not with NA).
Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
Loss of HBsAg (spontaneously or under NA)
Patients with loss of HBsAg (spontaneously or under NA). This group will allow comparison of the HBsAg loss immuno-virological profile with that of patients with active infection and varying levels of HBsAg (groups 1-3 and 5) and aid in identifying of predictors of functional cure. The identification of determinants of HBV functional cure is fundamental and is comparable to investigations that have been carried out in HIV-infected "elite controllers".
Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
Patients co-infected with HBV and HDV
Patients co-infected with HDV (positive HDV viral load), regardless of HBsAg level (presence or absence of HBV or HDV treatment)
Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
Interventions
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Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique
The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.
After echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.
A single FNA will be performed during the study.
Creation of a serum biobank
42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.
FNA feasibility and acceptability questionnaire
An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.
Eligibility Criteria
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Inclusion Criteria
* Patients chronically infected with hepatitis B virus at any stage of infection
* Nucleoside Analogues-treated or untreated
* Co-infected or not with HDV
* Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458)
* Patient informed of the study and having signed a consent form
Exclusion Criteria
* Patients with decompensated cirrhosis
* Patients with hepatocellular carcinoma (suspected or proven),
* Liver transplant patients (even if liver transplantation for HBV),
* Patients co-infected with HCV (positive serum viral load) and/or HIV (regardless of serum viral load).
* Patients participating at the time of inclusion in an interventional study
* Persons under psychiatric care,
* Persons admitted to a health or social institution for purposes other than research
* Adults under legal protection (legal guardianship, tutorship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme.
* Patients with abdominal skin lesions and/or infections.
* Contraindication to lidocaine administration (allergy or hypersensitivity to the product).
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Fabien ZOULIM, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Service d'Hépatologie de l'Hopital Croix-Rousse
Locations
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Hepatology Department - Hospices Civils de Lyon
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL23_0275
Identifier Type: -
Identifier Source: org_study_id
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