HELICOBACTER PYLORI INFECTIONSHED-2TNCT07821294
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Clinique Bizet at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- q-PCR on FFPE gastric biopsies
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 6 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Benkessou
Paris, 75016
BOUCHRA benkessou, 0764486016, b.benkessou@hexagone-sante-paris.fr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- q-PCR on FFPE gastric biopsies
- Keywords
- Helicobacter pylori, Clarithromycin Resistance, Helicobacter pylori Infection, Real-Time PCR, qPCR, FFPE Gastric Biopsies, 23S rRNA Mutations, Gastric Biopsy, Antibiotic Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
q-PCR on FFPE gastric biopsiesDiagnostic test
Real-time PCR performed on formalin-fixed, paraffin-embedded (FFPE) gastric biopsy specimens to detect Helicobacter pylori and mutations associated with clarithromycin resistance.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 days after gastric biopsy collection
Secondary outcomes (5)
Prevalence of clarithromycin resistance in Helicobacter pylori infection
Prevalence of clarithromycin resistance-associated mutations according to age, sex, clinical indication and clinical setting.
Measured: Within 10 days after gastric biopsy collection
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.
Measured: Within 15 days after gastric biopsy collection
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).
Measured: Within 15 days after gastric biopsy collection
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.
Measured: Within 15 days after inclusion and availability of laboratory results
Medical-economic impact of q-PCR FFPE strategy
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.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion6 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Michaël Lévy, Principal investigator, Clinique Bizet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821294
- Sponsor's protocol ID
- 2026-A01143-48
- Other IDs
- 2026-A01143-48
- Acronym
- HED-2T
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31068413Schmitt 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.
PubMed 23579617Oleastro 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.
PubMed 12517879Malfertheiner 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.
PubMed 35944925