Clinical trial · Observational
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.
NCT06347588CI-TRIAL-00099577active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Occult Hepatitis B Infection in Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 3 weeks after first cycle of therapy and every 3 months until the end of the study
- description
- 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 outcomes (3)
- measure
- Evaluation of the incidence of reactivation in patients during immunotherapy
- timeFrame
- 3 weeks after first cycle of therapy and every 3 months until the end of the study
- description
- Evaluation of the incidence of reactivation in patients during immunotherapy
- measure
- Evaluation of the association between HBV-specific T-cell response and HBV reactivation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.