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The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients treated with intravesical instillations for non-invasive bladder cancer |
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| Cohort B | Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer |
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| Cohort C | Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological samples | Other | Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor antigen specific T-cell responses | Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline. | 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C) |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of T cells in the blood | Flow cytometry analysis using T cell markers for : activation (ICOS, CD137, OX40), differenciation (CD45RA, CCR7, CD62L, CD95), cytotoxicity (perforin, granzyme B, GNLY, SlamF7) and exhaustion (PD-1, TIM-3, TIGIT, TCF1, CD39) | 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for a bladder cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihane Boustani, MD, PhD | Contact | +33 3 70 63 23 02 | jboustani@chu-besancon.fr |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Monitoring of immune cell death parameters in the blood | ATP and HMGB1 by ELISA test | 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C) |
| Monitoring of immune suppressive cells in the blood | Flow cytometry analysis using Treg markers (CD3, CD4, CD25, CD127, Foxp3) and monocytic MDSC (CD14, CD11b, CD33, HLA-DR, and lineage cocktail CD3 CD19 CD56). | 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C) |
| Overall survival | Time between the date of diagnosis and the date of death from any cause | Date of death from any cause (within 2 years after the initiation of the treatment) |
| Progression-free survival | Time interval between the date of diagnosis and the date of first progression (local, pelvic, metastatic [extent of the disease by RECIST v1.1]) or death from any cause | date of first progression of the disease (within 2 year after the initiation of the treatment) |
| Local progression-free survival | Time interval between the date of diagnosis and the date of first local progression or death from any cause | date of first local progression of the disease (within 2 year after the initiation of the treatment) |
| Transcriptomic analysis | Expression of genes of the anti-tumor responses in blood and tumor | At baseline |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |