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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Prospective observational study to assess bone predictive biomarkers for TKI response in RCC patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in the assessment of metastatic lesions at bone level and at other sites.
Prospective observational study to assess:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCC patients with bone metastases | Patients will receive the standard TKI treatment for first line treatment naive metastatic RCC. Sunitinib or pazopanib as decided by the investigator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess bone biomarkers in response to TKI | Assess the predictive value to TKI of bone biomarkers (bone formation BAP, P1NP, OPG and osteocalcin, and bone resorption biomarkers CTX) in patients with RCC with bone metastases. | Every 3 months until an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Assess the efficacy of TKI in patients with RCC with bone metastases. | An average of 12 months |
| Objective response rate | Assess the efficacy of TKI in patients with RCC with bone metastases. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with a diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Vazquez, MD | Hospital Univ Lucus Augusti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Donostia | San Sebastián | Guipuzcoa | 20080 | Spain | ||
| Complejo Hospitalario Univ de Santiago de Compostela |
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Blood plasma samples
| An average of 12 months |
| Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy | Comparison of the sensibility and specificity of whole body magnetic resonance and bone scintigraphy in the detection of metastases and response assessment of bone metastases in RCC | Every 3 months until an average of 12 months |
| Change and correlation of magnetic resonance and CT results in the assessment of global disease response to TKI. Using RECIST and MASS criteria | Compare globally the magnetic resonance and CT results in the assessment of disease response to TKI using RECIST and MASS criteria | Every 3 months until an average of 12 months |
| Quality of life of patients with RCC and bone metastases throughout the study period using the FSI-15 | Assess the quality of life of patients with RCC and bone metastases using the 15 item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-15) | Every 3 months until an average of 12 months |
| Quality of life of patients with RCC and bone metastases throughout the study period using FACT-BP | Assess the quality of life of patients with RCC and bone metastases using the FACT-BP questionnaire | Every 3 months until an average of 12 months |
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period | Assess the efficacy of TKI in the improvement of pain produced by bone metastases assessing the use of analgesics. | every week until an average of 12 months |
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period using the NPR scale | Assess the efficacy of TKI in the improvement of pain produced by bone metastases using the Numeric Pain Rating Scale | every week until an average of 12 months |
| Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period | Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab | every week until an average of 12 months |
| Santiago de Compostela |
| La Coruña |
| 15706 |
| Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario Univ de Vigo | Vigo | Pontevedra | 36204 | Spain |
| Hospital Universitario central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Consorcio Hospitalario Parc Tauli | Barcelona | 08208 | Spain |
| Complejo Hospitalario de León | León | 24071 | Spain |
| Hospital Univ Lucus Augusti | Lugo | 27003 | Spain |
| Complejo Hospitalario de Ourense | Ourense | 32005 | Spain |
| Instituto Valenciano de Oncologia | Valencia | 46009 | Spain |
| Hospital Universitario La Fe | Valencia | 46026 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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