Bladder Cancer Clinical Trial
— ICH-MIM-01Official title:
Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer
NCT number | NCT04256616 |
Other study ID # | 2041 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 27, 2018 |
Est. completion date | September 30, 2020 |
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
Status | Recruiting |
Enrollment | 110 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Humanitas reseach hospital (ICH) | Rozzano | Milan |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MMC-induced ICD | The main aim of this study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues. | 3 years | |
Secondary | ICD signature analyzed by RNAseq analysis | Identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature') | 3 years | |
Secondary | Microbiota study | Verify the existance of urinary microbiome using catheterized urines and identify changes in urinary microbiome composition correlating with bldder cancer, MMC efficacy and staging/progression of the disease | 3 years |
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