Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

707 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-03-31

Brief Summary

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This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer.

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Detailed Description

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The project is based on three prospective cohorts of patients with MIBC: the VESPER trial (n=296), the St-Louis Hospital cohort (n=99), and the COBLAnCE cohort (n=312). Using WES and RNAseq, the investigators will determine genomic instability, DDR gene mutation and molecular subtypes. After digitization of tumour slides, the investigators will train and test predictive models based on deep learning approaches to predict outcome after neoadjuvant chemotherapy, either by estimating molecular subtypes and genetic features from pathological images, or by directly defining a prognostic signature. The statistical analyses will assess the performance of the models combining genomic instability, DNA Damage Response mutations and/or molecular subtyping to predict outcome after neoadjuvant chemotherapy and compare them with the models based on WSI deep learning approaches. These results will help to design new therapeutic strategies.

Conditions

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Bladder Cancer Genomic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients enrolled in VESPER study

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort

neoadjuvant chemotherapy with cisplatine

Intervention Type COMBINATION_PRODUCT

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Patients from St Louis cohort not enrolled in VESPER study

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort

neoadjuvant chemotherapy with cisplatine

Intervention Type COMBINATION_PRODUCT

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Patients from COBLAnCE cohort not enrolled in VESPER study

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in COBLAnCE cohort

neoadjuvant chemotherapy with cisplatine

Intervention Type COMBINATION_PRODUCT

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Interventions

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neoadjuvant chemotherapy with cisplatine

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

Blood and tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort and :

having signed an informed consent form for the participation to the collection or dead/lost to follow-up without prior opposition expressed against research program, genetic analysis will only be carried out for patients who have signed the genetic consent form.

Blood and tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort and :

being informed for the participation to the collection and not having expressed opposition against research program or dead/lost to follow-up without prior opposition expressed against research program,

Blood and tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in COBLaNCE cohort and :

being informed for the participation to the collection and not having expressed opposition against research program or dead/lost to follow-up without prior opposition expressed against research program,