TerminatedNot Applicable

Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients

Stopped: The target enrollment was not reached at the end of recrutement period. The presence of a concurrent therapeutic clinical trial in the same department significantly limited patient availability for this study, making further recruitment not feasible.

France20 participantsStarted 2021-07-30

Plain-language 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 standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion diagnostic test). cfDNA can be detected not only in plasma but also in urine, even in patients with non-invasive disease. Recent studies found that the detection of genomic alterations in plasma of urothelial bladder carcinoma patients was relatively uninformative in the localized setting. However, urine cfDNA has been shown to provide a promising resource for robust whole-genome tumor profiling in clinically localized Muscle invasive Bladder cancer (MIBC) and Non-Muscle Invasive Bladder Cancer (NMIBC). Genomic alterations using a targeted next-generation sequencing (NGS) panel have been recently documented in a series of treatment-naïve high-risk NMIBC. The investigator's aim is to determine whether liquid biopsies can be used as a new diagnostic assay to guide immunotherapeutic approaches in patients with high-risk NMIBC. The ultimate goal is to develop a "testing decision tree" to segment patients for informing on therapeutic decision and customizing treatment.

Who can participate

Age range18 Years

SexALL

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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 - A…

What they're measuring

Agreement rate between urine cell-free DNA and tumor tissue mutation profile

Timeframe: Day 0

Trial details

NCT IDNCT04412070

SponsorHopital Foch

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30