Prognostic Performance of a Chemogram in Patients With Bladder Cancer.

Urinary Bladder Neoplasms Clinical Trial

— CHEMOGRAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403202
• Other study ID #: RC-P0095
• Status: Recruiting
• Start date: August 23, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Lille Catholic University
• Contact: Marie-Paule Lebitasy
• Phone: 033 3 20 22 52 69
• Email: lebitasy.marie-paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
France	Hôpital St Philibert	Lomme

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemogram sensitivity	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
Primary	Chemogram specificity	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
Primary	Positive predictive value	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
Primary	Negative predictive value	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	Proteomic analysis	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
Secondary	Transcriptomic analysis	and/or transcriptomic	12 months