A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV… (NCT07684209) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid
China200 participantsStarted 2026-08-01
Plain-language summary
The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two methods will be used for parallel testing. The main objective is to evaluate the quantitative consistency of the two methods within the quantifiable range of Roche (≥ 20 IU/mL); the secondary objectives include evaluating the qualitative detection rate of samples with concentrations below 20 IU/mL or undetectable nucleic acid.
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
. Patients who have been diagnosed with chronic hepatitis B (in accordance with the diagnostic criteria of the "Chronic Hepatitis B Prevention and Treatment Guidelines (2022 Edition)") and are currently receiving NAs antiviral treatment for ≥ 6 months or have not received treatment and are ≥ 18 years old;
. Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
. The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
. Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.
Exclusion criteria
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
quantitative consistency
Timeframe: "Baseline, single cross-sectional testing at sample collection, through study completion"
Trial details
NCT IDNCT07684209
SponsorBeijing Municipal Administration of Hospitals