Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori

NCT07821294 | Not Yet Recruiting

• 1 other identifier: 2026-A01143-48
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; Clarithromycin Resistance; Helicobacter pylori Infection; Real-Time PCR; qPCR; FFPE Gastric Biopsies; 23S rRNA Mutations; Gastric Biopsy; Antibiotic Resistance

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 10 days after gastric biopsy collection

Secondary Outcomes (5)

• Prevalence of clarithromycin resistance in Helicobacter pylori infection

  Within 10 days after gastric biopsy collection

• Concordance between q-PCR FFPE and immunohistochemistry results

  Within 15 days after gastric biopsy collection

• Concordance between q-PCR FFPE and bacteriological PCR results

  Within 15 days after gastric biopsy collection

• Impact of q-PCR results on therapeutic management

  Within 15 days after inclusion and availability of laboratory results

• Medical-economic impact of q-PCR FFPE strategy

  Through study completion, an average of 12 months

Interventions

q-PCR on FFPE gastric biopsies DIAGNOSTIC_TEST

Real-time PCR performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsy specimens to detect Helicobacter pylori and mutations associated with clarithromycin resistance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (1)

Benkessou

Paris, 75016, France

Location

Related Publications (4)

• Nezami BG, Jani M, Alouani D, Rhoads DD, Sadri N. Helicobacter pylori Mutations Detected by Next-Generation Sequencing in Formalin-Fixed, Paraffin-Embedded Gastric Biopsy Specimens Are Associated with Treatment Failure. J Clin Microbiol. 2019 Jun 25;57(7):e01834-18. doi: 10.1128/JCM.01834-18. Print 2019 Jul.

  PMID: 31068413 BACKGROUND

• Schmitt BH, Regner M, Mangold KA, Thomson RB Jr, Kaul KL. PCR detection of clarithromycin-susceptible and -resistant Helicobacter pylori from formalin-fixed, paraffin-embedded gastric biopsies. Mod Pathol. 2013 Sep;26(9):1222-7. doi: 10.1038/modpathol.2013.48. Epub 2013 Apr 12.

  PMID: 23579617 BACKGROUND

• Oleastro M, Menard A, Santos A, Lamouliatte H, Monteiro L, Barthelemy P, Megraud F. Real-time PCR assay for rapid and accurate detection of point mutations conferring resistance to clarithromycin in Helicobacter pylori. J Clin Microbiol. 2003 Jan;41(1):397-402. doi: 10.1128/JCM.41.1.397-402.2003.

  PMID: 12517879 BACKGROUND

• Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.

  PMID: 35944925 BACKGROUND

Study Officials

• Dr Michaël Lévy

  Clinique Bizet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bouchra BENKESSOU

CONTACT

07 64 48 60 16; b.benkessou@hexagone-sante-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 6, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)