Prognostic Performance of a Chemogram in Patients With Bladder Cancer.

NCT ID: NCT06403202

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2024-08-31

Brief Summary

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.

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.

Conditions

Urinary Bladder Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis Bonnal

Role: PRINCIPAL_INVESTIGATOR

GHICL

Locations

Hôpital St Philibert

Lomme, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie-Paule Lebitasy

Role: CONTACT

lebitasy.marie-paule@ghicl.net

033 3 20 22 52 69

Berenice MARCHANT

Role: CONTACT

marchant.berenice@ghicl.net

03.20.22.57.51

Facility Contacts

Jean-Louis Bonnal

Role: primary

bonnal.jean-louis@ghicl.net

Other Identifiers

RC-P0095

Identifier Type: -

Identifier Source: org_study_id