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The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.
Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.
Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofanenib and Hypophosphatemia | Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Sorafenib 800mg/die oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration | Assess the effects of sorafenib hormones involved in phosphate homeostasis | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Identify metabolic differences between renal cells cancer and hepatocarcinoma | identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma. | one year |
| Identify variations on bone mass during sorafenib treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced renal cells carcinoma and hepatocarcinoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfredo Berruti | Recruiting | Orbassano (To) | Turin | 10043 | Italy |
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Serum analites involved in phosphate homeostasis
Assess Sorafenib effects on bone density and the relationship with phosphate related hormones
| one year |
| Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability | Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity). | one year |
| Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival) | one year |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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