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Changes in the indication for Sunitinib in metastatic renal cell carcinoma, which have led to a significant decrease in its use in the urology department. Collected data will not be sufficient to perform a statistical analysis.
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Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer.
Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Biological | blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1 |
| Measure | Description | Time Frame |
|---|---|---|
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 1 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 2 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 3 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 4 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 5 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib |
| Measure | Description | Time Frame |
|---|---|---|
| plasma desethyl-Sunitinib (DES) concentration | influence of plasma DES concentration on patients survival | Cycle1 Day14 (each cycle is 28 days) |
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de ROUEN | Rouen | 76031 | France |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib |
| At the end of Cycle 6 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 1 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 2 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 3 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 4 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 5 (each cycle is 28 days) |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 6 (each cycle is 28 days) |
| Cycle1 Day14 (each cycle is 28 days) |
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survivall | Cycle1 Day28 (each cycle is 28 days) |
| plasma DES concentration | influence of plasma Sunitinib concentration on patients survival | Cycle1 Day28 (each cycle is 28 days) |
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle2 Day28(each cycle is 28 days) |
| plasma DES concentration | influence of plasma DES concentration on patients survival | Cycle2 Day28 (each cycle is 28 days) |
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle3 Day28 (each cycle is 28 days) |
| plasma DES concentration | Evaluate the influence of plasma DES concentration on patients survival | Cycle3 Day28 (each cycle is 28 days) |
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle6 Day28 (each cycle is 28 days) |
| plasma DES concentration | influence of plasma DES concentration on patients survival | Cycle6 Day28 (each cycle is 28 days) |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |