Status:
TERMINATED
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
Lead Sponsor:
Hopital Foch
Collaborating Sponsors:
AstraZeneca
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Common Inclusion Criteria
- Age ≥18 years at the time of screening.
- Capable of giving signed informed consent
- BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible).
- No prior radiotherapy to the bladder.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- At screening, tumor tissue provision from the initial surgery, formalin-fixed and paraffin-embedded (FFPE) is mandatory for DNA extraction and next-generation sequencing.
- Absence of metastasis, as confirmed by a negative CT or MRI scan of the pelvis, abdomen and chest, no more than 4 weeks prior to the enrolment.
- Life expectancy of at least 12 weeks.
- Must be a candidate for BCG treatment.
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL Absolute neutrophil count ≥1.0 × 109/L Platelet count ≥75 × 109/L Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN Measured creatinine clearance (CL) \>40 mL/min or calculated creatinine CL \>40 mL/min as determined by Cockcroft-Gault (using actual body weight) Males Creatinine CL = (Weight (kg) × (140 - Age))/(72 × serum creatinine (mg/dL)) (mL/min)
- Females Creatinine CL = (Weight (kg) × (140 - Age) )/(72 × serum creatinine (mg/dL)) × 0.85 (mL/min) - Being covered by a national health insurance
- Specific Inclusion Criteria for Non-Muscle Invasive Bladder Cancer (NMIBC) group
- Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa (predominantly urothelial even though mixed histology are allowed). A high-risk tumor is defined as one of the following:
- T1 tumor
- High grade/G3 tumor
- CIS
- Multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
- Complete resection of all Ta/T1 papillary disease prior to enrolment, with the most recent TURBT (Trans Urethral Resection of Bladder Tumor) occurring 2 months or less prior to signing informed consent for this study. Patients with residual CIS after TURBT are eligible.
- At least one additional resection of the primary tumor has been performed in case of T1 tumors, or incomplete initial TURB, or in case of doubt about the completeness of a TURB, or if there is no muscle in the specimen (can be omitted if primary CIS (In situ cancer) only was found.)
- Specific Inclusion Criteria for Muscle Invasive Bladder Cancer (MIBC) group Patients with histologically proven muscle-invasive bladder cancer (MIBC) scheduled before radical cystectomy.
- Non-Inclusion Criteria:
- Common Non-inclusion Criteria
- Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment (ie, clinical candidates of cystectomy and/or chemotherapy, etc are excluded).
- Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment.
- Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
- Any concurrent chemotherapy, Intra Peritoneal, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- Concurrent treatment with systemic immunostimulatory agents prior to the first dose of study treatment.
- History of allogenic organ transplantation. Patients with any history of allogenic stem cell transplantation are also excluded
- History of active primary immunodeficiency
- Pregnant or breastfeeding women
- Being deprived of liberty or under guardianship
- Specific Non-inclusion Criteria for NMIBC group
- \- Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or stage IV)
Exclusion
Key Trial Info
Start Date :
July 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04412070
Start Date
July 30 2021
End Date
June 30 2025
Last Update
November 21 2025
Active Locations (1)
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1
Foch hospital
Suresnes, France, 92151