Feasibility of FFPE qPCR to Detect H. pylori and Clarithromycin Resistance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center observational study will use formalin-fixed, paraffin-embedded gastric biopsy blocks obtained during routine gastroscopy to perform real-time PCR for detecting H. pylori and 23S rRNA mutations linked to clarithromycin resistance. The feasibility and diagnostic performance of FFPE qPCR will be compared to standard histology, immunohistochemistry, and bacteriological PCR. The study will also explore how qPCR results might influence treatment decisions and the potential economic impact of adopting this diagnostic approach. Adults undergoing gastroscopy for suspected H. pylori infection will be enrolled if histology and IHC confirm infection, and eligible FFPE blocks will be analyzed. This is an observational assessment to determine whether routine tissue samples can reliably support resistance testing.

Why it matters

Who can join: the full rules

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 (\<4 weeks) that may affect bacterial load.
* Recent proton pump inhibitor treatment (\<2 weeks).
* Insufficient tissue quantity for complementary analyses.
* Poor quality fixation or preservation of samples.

Where it's running

• Benkessou
  Paris, France Recruiting

Study contacts

• Principal investigator: Dr Michaël Lévy — Clinique Bizet
• Study coordinator: Bouchra BENKESSOU
• Email: b.benkessou@hexagone-sante-paris.fr
• Phone: 07 64 48 60 16

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.