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NCT07821294
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
Conditions: HELICOBACTER PYLORI INFECTIONS
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: Clinique Bizet
Location: Benkessou Paris
Summary
This prospective observational study aims to evaluate the feasibility and performance of real-time PCR (qPCR) performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsies to detect Helicobacter pylori infection and clarithromycin resistance. The study will assess whether qPCR performed on tissue samples routinely collected for histological examination can reliably identify H. pylori and mutations associated with clarithromycin resistance. Results will be compared with histology, immunohistochemistry, and bacteriological PCR. The study will also assess the potential impact of qPCR results on treatment decisions and the medical-economic impact of this diagnostic strategy.This prospective observational study aims to evaluate the feasibility and performance of real-time PCR (qPCR) performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsies to detect Helicobacter pylori infection and clarithromycin resistance. The study will assess whether qPCR performed on tissue samples routinely collected for histological examination can reliably identify H. pylori and mutations associated with clarithromycin resistance. Results will be compared with histology, immunohistochemistry, and bacteriological PCR. The study will also assess the potential impact of qPCR results on treatment decisions and the medical-economic impact of this diagnostic strategy.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* Ability to provide non-opposition to participate in the study.
* Participants with suspected Helicobacter pylori infection requiring gastric biopsies during gastroscopy for H. pylori assessment by histopathology and bacteriology, including clarithromycin resistance testing by PCR.
* Confirmed presence of Helicobacter pylori by histological examination and immunohistochemistry.
Exclusion Criteria:
* Minor participants.
* Adults under legal protection, guardianship or curatorship.
* Refusal to participate in the study.
* Recent antibiotic therapy (\
Source: ClinicalTrials.gov (NCT07821294). StuddyBuddy aggregates publicly available trial information.
