Clinical trial · Observational
Role of Microbiome in BCG Responsiveness Prediction
Towards Individualization of Bladder Cancer Therapy: the Role of Microbiome in BCG Responsiveness Prediction
NCT05204199CI-TRIAL-00075767SILENTEMPIREunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Group A
- description
- Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P)
- label
- Group B
- description
- Low Risk NMIBC (primary, solitary, Ta / low grad \< 3cm, no carcinoma in situ (CIS))
- label
- Group C
- description
- NMIBC patients, BCG candidates, assessed as intermediate (between the category of low- and high risk) or high risk (T1 or high grade or CIS or multiple, recurrent and large (\> 3 cm) Ta/ low grade tumours).
Primary outcomes (1)
- measure
- Difference in microbial Profile
- timeFrame
- 1 year
- description
- use of microbial profile from the bladder and the feces of NMIBC patients as a potential binary classification system, to substratify BCG-candidates into "anticipated BCG-responder (aBCGr)" and "anticipated BCG-non-responder (aBCGnr)" groups in predicting therapy response prior to BCG administration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria * Signed informed consent * Ability to understand and follow study procedures and understand informed consent * age 18 - 90 years Exclusion Criteria * Antibiotic treatment within the last month * Immuno-/chemotherapy within the past 6 months * Immunosuppressive therapy * Major medical, neoplastic (with the exception of skin cancer), surgical or psychiatric condition requiring ongoing management. Minor, well-controlled conditions, such as medically controlled arterial hypertension or occupational asthma, may be present. * Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder) * Major past intestinal surgery, especially in small intestine or colon. Cholecystectomy, appendectomy, past perianal surgery or past hernia repair may be present. * Major gastrointestinal symptoms (diarrhoea, constipation, abdominal pain, vomiting, unexplained weight loss, rectal bleeding or blood in the stool) * Bladder augmentation surgery. * Indwelling urinary catheter
References
Publications (1)
- DERIVEDBieri U, Scharl M, Sigg S, Szczerba BM, Morsy Y, Ruschoff JH, Schraml PH, Krauthammer M, Hefermehl LJ, Eberli D, Poyet C. Prospective observational study of the role of the microbiome in BCG responsiveness prediction (SILENT-EMPIRE): a study protocol. BMJ Open. 2022 Apr 18;12(4):e061421. doi: 10.1136/bmjopen-2022-061421. PMID 35437256