Urinary Bladder Neoplasms
Conditions
Keywords
Urinary Bladder Neoplasms, Chemogram
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.
Interventions
None listed
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Lille Catholic University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value | 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. |
| Chemogram specificity | 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. |
| Positive predictive value | 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. |
| Chemogram sensitivity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteomic analysis | 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 |
| Transcriptomic analysis | 12 months | and/or transcriptomic |
Countries
France
Contacts
Primary ContactMarie-Paule Lebitasy
Backup ContactBerenice MARCHANT
Outcome results
None listed