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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Occult Hepatitis B Infection in Cancer Patients

Treatments: Other: Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA

Study type: Observational

Funder types: Other

Identifiers

NCT06347588

OBI&ICI

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)