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NCT05204199: SILENTEMPIRE
Role of Microbiome in BCG Responsiveness Prediction
trial in Microbiome in 120 participants. Currently enrolling.
20 October 2025
Quick facts
| Lead sponsor | Cédric Poyet |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 22 February 2022 |
| Primary completion | 20 October 2025 |
| Estimated completion | 20 October 2025 |
| Sites | 5 locations across Switzerland |
Conditions studied
- Microbiome — all drugs for Microbiome →
- Bladder Cancer — all drugs for Bladder Cancer →
Sponsor
Cédric Poyet
Who can join
Adults 18 to 90, any sex, with Microbiome or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration. Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Urinary Microbiome in Health and Disease: Relevance for Bladder Cancer.
Kustrimovic N, Bilato G, Mortara L, Baci D. · · 2024 · cited 12× · PMID 38339010 · DOI 10.3390/ijms25031732 -
Prospective observational study of the role of the microbiome in BCG responsiveness prediction (SILENT-EMPIRE): a study protocol.
Bieri U, Scharl M, Sigg S, Szczerba BM, et al · · 2022 · cited 12× · PMID 35437256 · DOI 10.1136/bmjopen-2022-061421 -
The Role of Tumor and Host Microbiome on Immunotherapy Response in Urologic Cancers.
Pfail J, Drobner J, Doppalapudi K, Saraiya B, et al · · 2024 · cited 6× · PMID 38846356 · DOI 10.33696/cancerimmunol.6.078 -
Examining the Role of Microbiota-Centered Interventions in Cancer Therapeutics: Applications for Urothelial Carcinoma.
Drobner JC, Lichtbroun BJ, Singer EA, Ghodoussipour S. · · 2023 · cited 5× · PMID 36938621 · DOI 10.1177/15330338231164196
Verify or expand the search:
- PubMed search for NCT05204199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05204199 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cédric Poyet
- Last refreshed: 5 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05204199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing