Occult Hepatitis B Infection in Cancer PatientsNCT06347588
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
An observational study of Occult Hepatitis B Infection in Cancer Patients, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occult Hepatitis B Infection in Cancer Patients
- What is being tested?
- Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid tumors who have an occult hepatitis B infection and who need to start immunotherapy treatment.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNAOther
Blood sample at baseline, week 4, month 3, 6, 9,12.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Secondary outcomes (3)
Evaluation of the incidence of reactivation in patients during immunotherapy
Evaluation of the incidence of reactivation in patients during immunotherapy
Measured: 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
Evaluation of the association between HBV-specific T-cell response and HBV reactivation
Measured: 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
Measured: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start6 Jun 2022
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occult Hepatitis B Infection in Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347588
- Sponsor's protocol ID
- OBI&ICI
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06347588
- Acronym / sponsor ID
- OBI&ICI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors who have an occult hepatitis B infection and who need to start immunotherapy treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNABlood sample at baseline, week 4, month 3, 6, 9,12. | Other | – |
Primary outcome
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
Time frame: 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.
3 secondary outcomes
Evaluation of the incidence of reactivation in patients during immunotherapy
Time frame: 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
Time frame: 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).
Time frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occult Hepatitis B Infection in Cancer Patients, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.