Skip to content

Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

Survival prEdiction in bLadder Cancer Patients Treated by nEoadjuvant Chemotherapy Before cysTectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06294054
Acronym
SELECT
Enrollment
707
Registered
2024-03-05
Start date
2023-04-01
Completion date
2026-03-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Genomic Instability

Keywords

Neoadjuvent chemotherapy, Molecular subtype, Bladder cancer, Genomic instability, Artificial intelligence

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Institut Curie
CollaboratorOTHER
University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

\- Inclusion Criteria of Patients enrolled in VESPER study: 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. \- Inclusion Criteria of Patients from St Louis cohort not enrolled in VESPER study: 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, \- Inclusion Criteria of Patients from St Louis cohort not enrolled in COBLaNCE study: 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,

Exclusion criteria

* Patients not fulfilling eligibility criteria

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survival3 yearsThe time from enrollment to progression or death

Secondary

MeasureTime frameDescription
Overall survival5 yearsThe time from enrollment to death

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026