Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.

Not yet recruiting

• Conditions: Occult Hepatitis B Infection in Cancer Patients

• Registration Number: NCT06347588
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Study Start: 2024-05
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Life-expectancy (as estimated by treating physician) ≥ 6 months;
• Patients HBsAg negative
• Patients HBcAb positive with or without HBV-DNA detectable
• Patients with cancer undergoing immunotherapy with or without chemotherapy

Exclusion Criteria

• Patients who did not give informed consent
• Patients under prophylaxis for HBV
• Patients vaccinated for hepatitis B
• Patients with HBsAg positivity
• Patients with HIV positivity
• Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use
• Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease)
• Patients with current active Hepatitis C virus (HCV-positive)
• Patients with hepatocellular carcinoma (HCC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV	3 weeks after first cycle of therapy and every 3 months until the end of the study	Occult hepatitis B (OBI) detectable in serum HBV DNA, negative antigen test surface hepatitis B (HBsAg) and with positivity to anti-HBc (OBI seropositive).; pOBI: Based on the intermittent detection of HBV DNA, we define pOBI (OBI potential) patients with negative HBV-DNA and positivity to anti-HBc.

Secondary Outcome Measures

Name	Time	Method
Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy).	3 weeks after first cycle of therapy and every 3 months until the end of the study	Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor
Evaluation of the incidence of reactivation in patients during immunotherapy	3 weeks after first cycle of therapy and every 3 months until the end of the study	Evaluation of the incidence of reactivation in patients during immunotherapy
Evaluation of the association between HBV-specific T-cell response and HBV reactivation	3 weeks after first cycle of therapy and every 3 months until the end of the study	Evaluation of the association between HBV-specific T-cell response and HBV reactivation

Trial Locations

Locations (1)

Irccs San Matteo Pavia; 🇮🇹 Pavia, PV, Italy