Bladder Cancer Clinical Trial
— MITOMARKER-MIMOfficial title:
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
NCT number | NCT04256122 |
Other study ID # | 1191 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 22, 2019 |
Est. completion date | December 31, 2020 |
Retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 recurrences |
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 | Immunohistochemestry analysis of biomarkers | perform an immunophenotypical analysis to assess the expression of key proteins involved in mitochondrial functionality in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy. | 1 year | |
Secondary | Correlation of biomarker expression with outcome | • To correlate the resulting phenotype with clinical/pathological response to adjuvant treatments (time to recurrence and presence of recurrence). | 1 year |
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