Prognostic Performance of a Chemogram in Patients With Bladder Cancer. (CHEMOGRAM)

May 6, 2024 updated by: Lille Catholic University

Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.

The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.

Study Overview

Status

Recruiting

Conditions

Urinary Bladder Neoplasms

Detailed Description

The project is based on the premise that treatments - particularly chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize treatment for each patient, while proposing an approach that is economically viable for our healthcare system. The chemogram is inspired by the principle of antibiograms, since it tests, for a given patient and in conjunction with oncologists, different chemotherapeutic or targeted treatment options based on clinical and anatomopathological data. These tests are carried out in vitro in academic research laboratories.

With this study, its proposed a "proof of concept" for the clinical use of chemograms in patients with superficial or infiltrating bladder cancer. The use of chemograms will have no impact whatsoever on the patient's treatment, which will be administered according to standard practice. Nevertheless, this study may help determine whether chemograms can detect tumor sensitivity to certain anti-cancer treatments.

In the years to come, the aim of this research work is to be able to guide the therapeutic management of patients whose tumours are resistant to the treatment envisaged (tumours with intrinsic resistance to treatment). This will avoid unnecessary treatments for the patient, often with very serious side effects.

For these two types of bladder tumour, the use of a chemogram to detect the tumour's chemosensitivity would make treatment more effective and rapid.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Berenice MARCHANT
Phone Number: 03.20.22.57.51
Email: marchant.berenice@ghicl.net

Study Contact Backup

Name: Marie-Paule Lebitasy
Phone Number: 033 3 20 22 52 69
Email: lebitasy.marie-paule@ghicl.net

Study Locations

France
- - Lomme, France, 59160
    - Recruiting
    - Hôpital St Philibert
    - Contact:
      
      Jean-Louis Bonnal
      
      Email: bonnal.jean-louis@ghicl.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer

Description

Inclusion Criteria:

Major patient
Patient with suspected bladder cancer likely to be treated with chemotherapy
Patient affiliated to a social security scheme

Exclusion Criteria:

Insufficient tumor volume
Patient under guardianship
Pregnant or breast-feeding women
Patient opposed to participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemogram sensitivity Time Frame: 12 months	The relevance of the chemogram to the patient's response to treatment will be assessed by calculating sensitivities, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.	12 months
Chemogram specificity Time Frame: 12 months	The relevance of the chemogram to the patient's response to treatment will be assessed by calculating specificity, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.	12 months
Positive predictive value Time Frame: 12 months	The relevance of the chemogram to the patient's response to treatment will be assessed by calculating positive predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.	12 months
Negative predictive value Time Frame: 12 months	The relevance of the chemogram to the patient's response to treatment will be assessed by calculating negative predictive value, the gold standard being the proven response of patients with infiltrative bladder tumors to treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomic analysis Time Frame: 12 months	Proteomic analysis will detect various endogenous compounds: metabolites, lipids, peptides and proteins. Protein profiles (chemo-sensitive cancer, chemo-insensitive cancer, non-cancer) can be identified. and/or transcriptomic	12 months
Transcriptomic analysis Time Frame: 12 months	and/or transcriptomic	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Jean-Louis Bonnal, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)