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.
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.
Minor participants.
Adults under legal protection, guardianship or curatorship.
Refusal to participate in the study.
Recent antibiotic therapy (<4 weeks) that may affect bacterial load.
Adults undergoing gastroscopy with gastric biopsies for suspected Helicobacter pylori infection. Participants must have confirmed H. pylori infection by histology and immunohistochemistry. Gastric biopsy samples will be analyzed by q-PCR on formalin-fixed paraffin-embedded (FFPE) tissue to evaluate detection of H. pylori and clarithromycin resistance-associated mutations.
Cohort
Prospective
q-PCR on FFPE gastric biopsies
Diagnostic testReal-time PCR performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsy specimens to detect Helicobacter pylori and mutations associated with clarithromycin resistance.
Diagnostic performance of q-PCR on FFPE gastric biopsies for detection of Helicobacter pylori clarithromycin resistance
Sensitivity and specificity of q-PCR performed on formalin-fixed paraffin-embedded (FFPE) gastric biopsies for: detection of Helicobacter pylori infection (using immunohistochemistry and internal PCR positive control as reference); detection of clarithromycin resistance-associated mutations (23S rRNA gene mutations); assessment of the proportion of exploitable samples (technical success rate); turnaround time for obtaining results.Sensitivity and specificity of q-PCR performed on formalin-fixed paraffin-embedded (FFPE) gastric biopsies for: detection of Helicobacter pylori infection (using immunohistochemistry and internal PCR positive control as reference); detection of clarithromycin resistance-associated mutations (23S rRNA gene mutations); assessment of the proportion of exploitable samples (technical success rate); turnaround time for obtaining results.
Prevalence of clarithromycin resistance in Helicobacter pylori infection
Prevalence of clarithromycin resistance-associated mutations according to age, sex, clinical indication and clinical setting.
Concordance between q-PCR FFPE and immunohistochemistry results
Agreement between q-PCR performed on FFPE gastric biopsies and immunohistochemistry results, particularly in cases with low bacterial load.
Concordance between q-PCR FFPE and bacteriological PCR results
Agreement between q-PCR performed on FFPE gastric biopsies and reference PCR performed on bacteriological samples (and culture when available).
Impact of q-PCR results on therapeutic management
Proportion of participants whose treatment strategy is modified based on q-PCR results, including prescription of a treatment guided by clarithromycin susceptibility profile.
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