NCT07684209Not yet recruiting
A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid
A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Diseases
- Hepatitis B
- NCT number
- NCT07684209
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Aug 2026 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Combine other liver virus infections such as HCV, HDV or HIV;
Other
- Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
- The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
- The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
- The duplicate samples already included at the same time point (only the first included sample is retained).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.