Occult Hepatitis B Infection in Cancer Patients
Conditions
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.
Interventions
OTHERObservational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA
Blood sample at baseline, week 4, month 3, 6, 9,12.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed