Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

NCT06294054 | Active Not Recruiting

• 1 other identifier: 2021/0393/HP
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 7

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.

Conditions

Bladder Cancer; Genomic Instability

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time from enrollment to progression or death

  3 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (3)

Patients enrolled in VESPER study

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

Combination Product: 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

Combination Product: 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

Combination Product: neoadjuvant chemotherapy with cisplatine

Interventions

neoadjuvant chemotherapy with cisplatine COMBINATION_PRODUCT

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

Patients enrolled in VESPER study; Patients from COBLAnCE cohort not enrolled in VESPER study; Patients from St Louis cohort not enrolled in VESPER study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cohorts of patients with MIBC (Muscle-invasive bladder cancer)

You may qualify if:

• 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,

You may not qualify if:

• Patients not fulfilling eligibility criteria

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Institut Curie: collaborator

Study Sites (7)

Centre de lutte contre le cancer François Baclesse

Caen, France

Location

Centre de recherche des Cordeliers

Paris, France

Location

Hôpital Saint-Louis AP-HP

Paris, France

Location

Institut Curie Centre de Recherche

Paris, France

Location

Institut Curie

Paris, France

Location

Institut Gustave Roussy

Paris, France

Location

Mines ParisTech

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 32868138 BACKGROUND

• 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.

  PMID: 35254888 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Genomic Instability

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Yves ALLORY, MD

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: April 1, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

FR (7)