Clinical trial NCT06403202: Prognostic Performance of a Chemogram in Patients With Bladder Cancer.
Official title: Prognostic Performance of a Chemogram in Patients With Intermediate-grade Superficial Bladder Cancer and Invasive Bladder Cancer: Proof of Concept.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Neoplasms
Keywords: Urinary Bladder Neoplasms
Chemogram
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate-grade superficial bladder cancer and invasive bladder cancer

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.

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

Primary outcomes:
measure: Chemogram sensitivity
timeFrame: 12 months
measure: Chemogram specificity
timeFrame: 12 months
measure: Positive predictive value
timeFrame: 12 months
measure: Negative predictive value
timeFrame: 12 months
Secondary outcomes:
measure: Proteomic analysis
timeFrame: 12 months
measure: Transcriptomic analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hôpital St Philibert
Study officials:
affiliation: GHICL
name: Jean-Louis Bonnal
role: PRINCIPAL_INVESTIGATOR
References: