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A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid

3. Juli 2026 aktualisiert von: Minghui Li, Beijing Municipal Administration of Hospitals

A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study aims to include a total sample size of approximately 200 cases: 100 positive cases: ≥ 1000 IU/mL: 40 cases; 100 - 1000 IU/mL: 30 cases; 20 - 100 IU/mL: 30 cases; 100 negative cases: lower than 20 IU/mL: 40 cases, and undetected: 60 cases. Collect the age, gender, duration of HBV infection, antiviral treatment drugs and treatment courses, HBeAg status, HBsAg quantification (if available), ALT/AST levels, date of blood sample collection, date and result of combas HBV DNA detection, and digital PCR detection results of the enrolled patients. By comparing the detection results of the two methods, evaluate the quantitative accuracy or qualitative detection ability of the digital PCR hepatitis B detection method.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100015
        • Beijing Ditan Hospital, Capital Medical University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

The research samples were derived from the routine diagnostic leftover serum samples of chronic hepatitis B patients who were treated at the outpatient or inpatient departments of Beijing Ditan Hospital, Capital Medical University. All the samples were the leftover samples obtained after the routine HBV DNA testing (combas HBV) was completed, and they were the secondary utilization of the leftover samples from clinical routine tests.

Beschreibung

Inclusion Criteria:

  1. 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;
  2. Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
  3. The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
  4. 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:

  1. Combine other liver virus infections such as HCV, HDV or HIV;
  2. Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
  3. The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
  4. The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
  5. The duplicate samples already included at the same time point (only the first included sample is retained).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
High-concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Sonstiges: the results were classified according to concentration levels
the results were classified according to concentration levels
medium concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Sonstiges: the results were classified according to concentration levels
the results were classified according to concentration levels
low concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Sonstiges: the results were classified according to concentration levels
the results were classified according to concentration levels
extremely low concentration group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Sonstiges: the results were classified according to concentration levels
the results were classified according to concentration levels
undetectable group
After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.
Sonstiges: the results were classified according to concentration levels
the results were classified according to concentration levels

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
quantitative consistency
Zeitfenster: "Baseline, single cross-sectional testing at sample collection, through study completion"
Evaluate the quantitative consistency of the self-developed digital PCR (ddPCR) method with the Roche Cobas TaqMan HBV DNA test (cobas HBV) within the quantifiable range (≥ 20 IU/mL)
"Baseline, single cross-sectional testing at sample collection, through study completion"

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Beijing Municipal Administration of Hospitals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2028

Studienabschluss (Geschätzt)

1. August 2028

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DTEC-KY2026-075-01

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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