Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

Bladder Cancer Clinical Trial

— SELECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06294054
• Other study ID #: 2021/0393/HP
• Status: Active, not recruiting
• Start date: April 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 707
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Combination Product:
• neoadjuvant chemotherapy with cisplatine
Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

Locations

Country	Name	City	State
France	Centre de lutte contre le cancer François Baclesse	Caen
France	Centre de recherche des Cordeliers	Paris
France	Hôpital Saint-Louis AP-HP	Paris
France	Institut Curie	Paris
France	Institut Curie Centre de Recherche	Paris
France	Institut Gustave Roussy	Paris
France	Mines ParisTech	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Institut Curie

Country where clinical trial is conducted

France, 

References & Publications (2)

Pfister C, Gravis G, Flechon A, Chevreau C, Mahammedi H, Laguerre B, Guillot A, Joly F, Soulie M, Allory Y, Harter V, Culine S; VESPER Trial Investigators. Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients With Nonmetastatic Muscle-Invasive Bladder Cancer: Results of the GETUG-AFU V05 VESPER Trial. J Clin Oncol. 2022 Jun 20;40(18):2013-2022. doi: 10.1200/JCO.21.02051. Epub 2022 Mar 7. — View Citation

Pfister C, Gravis G, Flechon A, Soulie M, Guy L, Laguerre B, Mottet N, Joly F, Allory Y, Harter V, Culine S; VESPER Trial Investigators. Randomized Phase III Trial of Dose-dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin, or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients with Muscle-invasive Bladder Cancer. Analysis of the GETUG/AFU V05 VESPER Trial Secondary Endpoints: Chemotherapy Toxicity and Pathological Responses. Eur Urol. 2021 Feb;79(2):214-221. doi: 10.1016/j.eururo.2020.08.024. Epub 2020 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The time from enrollment to progression or death	3 years
Secondary	Overall survival	The time from enrollment to death	5 years