Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy. (NCT06347588) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Italy60 participantsStarted 2022-06-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Trial details
NCT IDNCT06347588
SponsorFondazione IRCCS Policlinico San Matteo di Pavia