Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

9 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic performance of q-PCR on FFPE gastric biopsies for detection of Helicobacter pylori clarithromycin resistance
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of clarithromycin resistance in Helicobacter pylori infection
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clinique Bizet

Investigatori

  • Investigatore principale: Dr Michaël Lévy, Clinique Bizet

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

28 febbraio 2027

Completamento dello studio (Stimato)

6 agosto 2027

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2026

Primo Inserito (Effettivo)

15 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2026-A01143-48 (Altro identificatore: ID-RCB)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi