Clinical trial · Observational
Expression of Markers Related to Mitochondrial Functionality in Carcinoma of the Urinary Bladder: Comparative Retrospective Analysis Between Recurrent Tumors ("Non-responders") and Non-recurrent Tumors ("Responders") After Intravesical Treatment With Chemotherapy or Immunotherapy
NCT04256122CI-TRIAL-00043419MITOMARKER-MIMunknownClinicalTrials.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)
Retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Responder patients
- description
- Patients with NMIBC at first diagnosis, pTa/pT1 (primary tumors) treated with MMC or BCG after TURBT will be selected from the institutional patient registry. * Patient treated with adjuvant MMC or BCG that did not experience recurrence for at least 42 months after TURBT * Patients are tumor-free at the moment of the analysis
- interventionNames
- Other: No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.
- label
- Non responder patients
- description
- Patients with NMIBC at first diagnosis, pTa/pT1 (primary tumors) treated with MMC or BCG after TURBT will be selected from the institutional patient registry. o Patient treated with adjuvant MMC or BCG that experienced recurrence in the first 24 months after TURBT.
- interventionNames
- Other: No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* \>18 years of age at diagnosis
* Histologically confirmed NMIBC urothelial carcinoma of the urinary bladder (pTa, pT1, CIS)
* Primary NMIBC or not treated secondary NMIBC, after a primary non-invasive malignancy
* Patients underwent TURBT for NMIBC at Humanitas between 2000 and 2019
* Patients that received intravesical instillations with either MMC or BCG after TURBT at Humanitas between 2000 and 2019
* Written informed consent to research purpose
* For non-recurrent tumors ("responders"):
* Patient treated with adjuvant MMC or BCG that did not experience recurrence for at least 42 months after TURBT
* Patients are tumor-free at the moment of the analysis
* For recurrent tumors ("non-responders"):
* Patient treated with adjuvant MMC or BCG that experienced recurrence in the first 24 months after TURBT.
Exclusion Criteria:
* Previous malignancies other that bladder cancer
* Patients with a history of treated bladder cancer recurrencesReferences
Publications (1)
- DERIVEDOresta B, Pozzi C, Braga D, Hurle R, Lazzeri M, Colombo P, Frego N, Erreni M, Faccani C, Elefante G, Barcella M, Guazzoni G, Rescigno M. Mitochondrial metabolic reprogramming controls the induction of immunogenic cell death and efficacy of chemotherapy in bladder cancer. Sci Transl Med. 2021 Jan 6;13(575):eaba6110. doi: 10.1126/scitranslmed.aba6110. PMID 33408185