Clinical Trials Logo

Clinical Trial Summary

Retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes


Clinical Trial Description

About 80% of newly diagnosed patients have non-muscle-invasive bladder cancer (NMIBC), including papillary lesions confined to the urothelium (stage Ta) or invading the lamina propria (stage T1), and carcinoma in situ (CIS). These tumors show low progression rates, but high recurrence. In particular, patients with multifocal high-grade urothelial carcinoma have a high risk of both recurrence (∼70% after 1 yr) and progression (5% after 1 yr). Initial NMIBC management is a transurethral resection of bladder tumor (TURBT), followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy Bacillus Calmette-Guérin (BCG). However, these therapies lead to variable clinical responses and patients recur shortly after surgery. Despite both therapies have been used for decades in the treatment of NMIBC, at the moment it is not possible to predict after initial staging which patients will benefit from them since neither resistance mechanisms nor genetic markers associated to relapse have been identified yet.

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04256122
Study type Observational
Source Istituto Clinico Humanitas
Contact Maria Rescigno, PhD
Phone +390282245431
Email maria.rescigno@hunimed.eu
Status Recruiting
Phase
Start date October 22, 2019
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06034015 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers Phase 1
Recruiting NCT04235764 - En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Completed NCT02371447 - VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Recruiting NCT04081246 - Transurethral Modified En Bloc Resection For Large Bladder Tumours. N/A
Recruiting NCT06059547 - Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer Phase 2
Terminated NCT04779489 - Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer N/A
Not yet recruiting NCT04493489 - Propranolol Adjuvant Treatment of Bladder Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04537221 - Nordic Cystectomy Study III - Transfusion
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05562791 - A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer Phase 1
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT02781428 - To Detect the Sensitivity of the UroMark Assay
Recruiting NCT04738630 - Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer Phase 2
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03978624 - Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A