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Clinical Study of Helicobacter pylori Nucleic Acid Assay Kit (Digital PCR Method)

Clinical Study of Helicobacter pylori Nucleic Acid Assay Kit (Digital PCR Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080081
Enrollment
Unknown
Registered
2024-01-19
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Gold Standard:Culture of Helicobacter pylori bacteria, drug sensitivity test results, and virulence gene cagA sequencing results
Index test:Helicobacter pylori Nucleic Acid Assay Kit (Digital PCR Method)

Sponsors

Qingyuan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who underwent gastroscopy procedure in hospital and retained gastric mucosal tissue for H. pylori culture. (2) Positive samples: Stool samples from patients with positive culture of H. pylori in the gastric mucosa were selected; (3) Negative samples: Stool samples from patients with negative culture of H. pylori in the gastric mucosa were selected; (4) Agreed to sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients already treated with antibiotics for H. pylori; sample contamination; insufficient sample volume.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Kappa value;ROC curve;—

Countries

China

Contacts

Public ContactLinhai Li

Qingyuan People's Hospital

mature303@126.com+86 188 1885 7232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026