Clinical trial NCT06294054: Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy
Official title: Survival prEdiction in bLadder Cancer Patients Treated by nEoadjuvant Chemotherapy Before cysTectomy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Genomic Instability
Keywords: Neoadjuvent chemotherapy
Molecular subtype
Bladder cancer
Genomic instability
Artificial intelligence
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2024-03-05
Enrollment: 707
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohorts of patients with MIBC (Muscle-invasive bladder cancer)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre de lutte contre le cancer François Baclesse
city: Paris
country: France
facility: Centre de recherche des Cordeliers
city: Paris
country: France
facility: Hôpital Saint-Louis AP-HP
city: Paris
country: France
facility: Institut Curie Centre de Recherche
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Institut Gustave Roussy
city: Paris
country: France
facility: Mines ParisTech
Study officials:
affiliation: Institut Curie
name: Yves ALLORY, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.