Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM) (SORHORM)
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|ClinicalTrials.gov Identifier: NCT01230697|
Recruitment Status : Unknown
Verified July 2010 by University of Turin, Italy.
Recruitment status was: Recruiting
First Posted : October 29, 2010
Last Update Posted : October 29, 2010
|Condition or disease||Intervention/treatment|
|Kidney Cancer Liver Cancer||Drug: Sorafenib|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib. Multicenter Cohort Study|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||September 2011|
Sofanenib and Hypophosphatemia
Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib
Sorafenib 800mg/die oral
- Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration [ Time Frame: one year ]Assess the effects of sorafenib hormones involved in phosphate homeostasis
- Identify metabolic differences between renal cells cancer and hepatocarcinoma [ Time Frame: one year ]identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.
- Identify variations on bone mass during sorafenib treatment [ Time Frame: one year ]Assess Sorafenib effects on bone density and the relationship with phosphate related hormones
- Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability [ Time Frame: one year ]Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity).
- Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival) [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230697
|Orbassano (To), Turin, Italy, 10043|
|Contact: Elisa Bellini, MD (+39) 011 9026 ext 526 firstname.lastname@example.org|
|Principal Investigator: Alfredo Berruti, PHD|
|Sub-Investigator: Isabella Chiappino, MD|
|Sub-Investigator: Cinzia Ortega, MD|
|Sub-Investigator: Mario Pirisi, PHD|
|Sub-Investigator: Antonino Picciotto, PHD|
|Sub-Investigator: Camillo Porta, MD|
|Sub-Investigator: Anna Pia, MD|
|Sub-Investigator: Elena Bianco, MD|