Clinical trial · Interventional
Immunological Response of Bladder Cancer Patients Under BCG
Systemic Immunological Response of Bladder Cancer Patients Under Bacillus Calmette Guérin Treatment
- 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)
Bladder cancer (BC) is one of the most common cancers worldwide and the most successful example of vaccine in cancer treatment, representing an efficient model for studying the importance of systemic and local immune mechanisms. Despite being the standard of treatment for the last 40 years, the exact mode of action of immunotherapy with the bacillus Calmette-Guérin (BCG) is still poorly defined. In a mechanistic study, the investigators intend to prospectively investigate immunological signatures, including immune-checkpoints, pre and post-treatment in patients with BC, and correlate the cytokines of the immune by-product and BCG administration pathway to understand the independent contributions of BCG priming (prior exposure to BCG) and crosstalk immunotherapy between tumor profiles and immune response of the patient. The proposed research strategy is justified by the need to identify subsets of patients who better respond to an intervention, or to predict why new immunotherapies and drugs may be successful or failed in clinical trials.
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 |
|---|---|---|---|
| Bacillus Calmette-Guerin | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette Guerin | Biological | — | UNRESOLVED |
| PLACEBO | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BCG intradermal vaccine
- description
- Intradermal BCG Group (n=16): 0.1 ml of lyophilized, live, and attenuated BCG intradermal vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose.
- interventionNames
- Biological: Bacillus Calmette Guerin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo group (n = 16): 0.9% saline solution in the same volume as BCG vaccine in a single dose.
- interventionNames
- Other: PLACEBO
Primary outcomes (6)
- measure
- Flow Cytometry
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * NMIBC with the indication for intravesical BCG treatment; Exclusion Criteria: * Previous BCG treatment; * Muscle invasive tumor.
References
Publications (2)
- BACKGROUNDJi N, Mukherjee N, Morales EE, Tomasini ME, Hurez V, Curiel TJ, Abate G, Hoft DF, Zhao XR, Gelfond J, Maiti S, Cooper LJN, Svatek RS. Percutaneous BCG enhances innate effector antitumor cytotoxicity during treatment of bladder cancer: a translational clinical trial. Oncoimmunology. 2019 May 25;8(8):1614857. doi: 10.1080/2162402X.2019.1614857. eCollection 2019. PMID 31413921
- BACKGROUNDvan Puffelen JH, Keating ST, Oosterwijk E, van der Heijden AG, Netea MG, Joosten LAB, Vermeulen SH. Trained immunity as a molecular mechanism for BCG immunotherapy in bladder cancer. Nat Rev Urol. 2020 Sep;17(9):513-525. doi: 10.1038/s41585-020-0346-4. Epub 2020 Jul 16. PMID 32678343