Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients (ALU)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04412070 |
Recruitment Status :
Recruiting
First Posted : June 2, 2020
Last Update Posted : August 31, 2022
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | May 28, 2020 | ||||
First Posted Date | June 2, 2020 | ||||
Last Update Posted Date | August 31, 2022 | ||||
Actual Study Start Date | July 30, 2021 | ||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Agreement rate between urine cell-free DNA and tumor tissue mutation profile [ Time Frame: Day 0 ] concordance rate between mutations identified in the tumor
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
Prognostic value of Tumor Mutation Burden (TMB) [ Time Frame: Day 0 ] TMB will be calculated in the urine cell-free DNA for Each patient
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients | ||||
Official Title | A Pilot Study to Assess the Concordance of Genomic Alterations Between Urine and Tissue to Develop Precision Medicine-Based Immunotherapy Approaches in High-Risk NMIBC Patients | ||||
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 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. |
||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
|
||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The study population concerns :
During their conventional follow-up, a urine collection will be performed to each patient for testing of cell-free DNA. Genomic analysis of the primary tumor will be carried out on the tumor samples resetced during the initial diagnosis. |
||||
Condition | Bladder Cancer | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
40 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 2025 | ||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Common Inclusion Criteria
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
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
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) |
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04412070 | ||||
Other Study ID Numbers | 2018_0087 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Current Responsible Party | Hopital Foch | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Hopital Foch | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | AstraZeneca | ||||
Investigators |
|
||||
PRS Account | Hopital Foch | ||||
Verification Date | August 2022 |