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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA | Other | Blood sample at baseline, week 4, month 3, 6, 9,12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 3 weeks after first cycle of therapy and every 3 months until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the incidence of reactivation in patients during immunotherapy | 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 association between HBV-specific T-cell response and HBV reactivation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with solid tumors who have an occult hepatitis B infection and who need to start immunotherapy treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs San Matteo Pavia | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D006514 | Hepatitis B Surface Antigens |
| ID | Term |
|---|---|
| D006511 | Hepatitis B Antigens |
| D018963 | Hepatitis Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
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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 |
| 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). | Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor | 3 weeks after first cycle of therapy and every 3 months until the end of the study |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |