Clinical trial NCT06347588: Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Official title: Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Occult Hepatitis B Infection in Cancer Patients
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid tumors who have an occult hepatitis B infection and who need to start immunotherapy treatment.

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.


Eligibility criteria: 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)

Primary outcomes:
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
Secondary outcomes:
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
measure: Evaluation of the association between HBV-specific T-cell response and HBV reactivation
timeFrame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
measure: 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).
timeFrame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Irccs San Matteo Pavia
state: PV
Study officials:
References: