Clinical trial · Observational
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
NCT04256616CI-TRIAL-00045819ICH-MIM-01unknownClinicalTrials.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)
The principal objective of this study consists in the assessment of Immunogenic Cell Death (ICD) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with Mitomycin C (MMC). The evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient
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 |
|---|---|---|---|
| This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Bladder cancer patients
- description
- 80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients
- interventionNames
- Other: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.
- label
- Controls- Healthy subjects
- description
- 30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of \>70 years old.
- interventionNames
- Other: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: \- Male and females, \> 40 years old For bladder cancer patients: \- bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy Exclusion Criteria: * Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment * Treated with antibiotics at time of enrollment or during the month before enrollment * Positive history of sexually transmitted diseases * Urinary infection ongoing or recent (during the three months before enrollment) * Suffering from chronic intestinal inflammation ONLY for controls: * Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment * Treated with antibiotics at time of enrollment or during the month before enrollment * Positive history of sexually transmitted diseases * Urinary infection ongoing or recent (during the three months before enrollment) * Suffering from chronic intestinal inflammation
References
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