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Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori (HED-2T)

9. september 2026 oppdatert av: Clinique Bizet

Feasibility and Performance of qPCR on Formalin-Fixed, Paraffin-Embedded Gastric Biopsies for Detection of Clarithromycin Resistance in Helicobacter Pylori in Routine Clinical Practice

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Helicobacter pylori (H. pylori) infection is a common chronic bacterial infection associated with peptic ulcer disease and gastric malignancies. Clarithromycin resistance is an important cause of treatment failure. Current recommendations support susceptibility-guided treatment based on the detection of clarithromycin resistance; however, in routine clinical practice, resistance testing remains infrequently performed.

This prospective, single-center observational study will evaluate the feasibility and diagnostic performance of real-time polymerase chain reaction (qPCR) performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsies collected during routine gastroscopy. The study will investigate whether FFPE tissue samples already obtained for histopathological examination can be used to detect H. pylori and mutations in the 23S rRNA gene associated with clarithromycin resistance.

Participants will be adults with suspected H. pylori infection who require gastric biopsies during gastroscopy. H. pylori infection will be confirmed by histological examination and immunohistochemistry. For participants with confirmed H. pylori infection, corresponding FFPE tissue blocks will be selected for DNA extraction and qPCR targeting mutations associated with clarithromycin resistance.

The primary objective is to prospectively evaluate the feasibility and performance of qPCR on FFPE gastric biopsies for the detection of clarithromycin resistance in H. pylori in routine clinical practice. Diagnostic performance will include sensitivity and specificity for H. pylori detection and for detection of clarithromycin-resistance mutations, as well as the proportion of samples yielding exploitable results and the time required to obtain results.

Secondary objectives include describing the prevalence and epidemiology of clarithromycin-resistance mutations in the study population; assessing concordance between FFPE qPCR and immunohistochemistry, particularly in cases with low bacterial load; assessing concordance between FFPE qPCR and bacteriological PCR; evaluating the potential impact of qPCR results on therapeutic management; and assessing the medical-economic impact of a clarithromycin-resistance screening strategy based on FFPE qPCR compared with empirical treatment and bacteriological PCR.

The study will include approximately 250 participants. The study is prospective and monocentric and does not involve any modification of the patient's usual clinical management. Gastric biopsies will be collected during routine gastroscopy and analyzed by pathology and bacteriology according to the study protocol. The planned inclusion period is July 2026 to January 2027, with a 10-day follow-up period.

Studietype

Observasjonsmessig

Registrering (Antatt)

250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic performance of q-PCR on FFPE gastric biopsies for detection of Helicobacter pylori clarithromycin resistance
Tidsramme: Within 10 days after gastric biopsy collection

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of clarithromycin resistance in Helicobacter pylori infection
Tidsramme: Within 10 days after gastric biopsy collection
Prevalence of clarithromycin resistance-associated mutations according to age, sex, clinical indication and clinical setting.
Within 10 days after gastric biopsy collection
Concordance between q-PCR FFPE and immunohistochemistry results
Tidsramme: Within 15 days after gastric biopsy collection
Agreement between q-PCR performed on FFPE gastric biopsies and immunohistochemistry results, particularly in cases with low bacterial load.
Within 15 days after gastric biopsy collection
Concordance between q-PCR FFPE and bacteriological PCR results
Tidsramme: Within 15 days after gastric biopsy collection
Agreement between q-PCR performed on FFPE gastric biopsies and reference PCR performed on bacteriological samples (and culture when available).
Within 15 days after gastric biopsy collection
Impact of q-PCR results on therapeutic management
Tidsramme: Within 15 days after inclusion and availability of laboratory results
Proportion of participants whose treatment strategy is modified based on q-PCR results, including prescription of a treatment guided by clarithromycin susceptibility profile.
Within 15 days after inclusion and availability of laboratory results
Medical-economic impact of q-PCR FFPE strategy
Tidsramme: Through study completion, an average of 12 months
Comparison of costs between q-PCR FFPE strategy and current empirical or bacteriological PCR-based strategies, including cost per adapted treatment and cost per avoided therapeutic failure.
Through study completion, an average of 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clinique Bizet

Etterforskere

  • Hovedetterforsker: Dr Michaël Lévy, Clinique Bizet

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

28. februar 2027

Studiet fullført (Antatt)

6. august 2027

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

15. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2026-A01143-48 (Annen identifikator: ID-RCB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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