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 ID: NCT04256122
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2019-10-22
2020-12-31
Brief Summary
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Detailed Description
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In a preliminary analysis, the invesitigators found that low expression of several proteins involved in mitochondrial functions correlate with a worst prognosis in bladder cancer patients. The aim of this study is to detect markers of mitochondrial dysfunction by immunohistochemistry in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy, and determine the prognostic relevance of these different markers.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Responder patients
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
No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.
evaluate an immunophenotypical profile related to mitochondrial functions in tumors responders vs non-responder to intravescical chemotherapy or immunotherapy. Verify the possible prognostic differences in clinical behavior between the two populations.
Non responder patients
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.
No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.
evaluate an immunophenotypical profile related to mitochondrial functions in tumors responders vs non-responder to intravescical chemotherapy or immunotherapy. Verify the possible prognostic differences in clinical behavior between the two populations.
Interventions
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No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.
evaluate an immunophenotypical profile related to mitochondrial functions in tumors responders vs non-responder to intravescical chemotherapy or immunotherapy. Verify the possible prognostic differences in clinical behavior between the two populations.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with a history of treated bladder cancer recurrences
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
Head of Clinical Research
Locations
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Humanitas reseach hospital (ICH)
Rozzano, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Oresta 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.
Other Identifiers
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1191
Identifier Type: -
Identifier Source: org_study_id
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