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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-06

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Occult Hepatitis B Infection in Cancer Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Blood sample at baseline, week 4, month 3, 6, 9,12.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Angioletta Lasagna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Irccs San Matteo Pavia

Pavia, PV, Italy

Site Status

Countries

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Italy

Other Identifiers

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OBI&ICI

Identifier Type: -

Identifier Source: org_study_id