Multicentric and prospective epidemiological study (NON INTERVETIONAL) to identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in metstatic renal cell carcinoma. Molecular determinations will be developed ay CIMA and CNIO.
In coming years new TKIs for the treatment of mRCC are expected to be available. Identificaction of novel biomarkers is required to select those patients who would most benefit from a particular therapeutic strategy: C-Met is a tyrosine kinase receptor involved in cellular growth and vascular develoment, also identify as a proto-oncogene. Chemiokines: an increase in pro-angiogenic chemokines such as IL-6 \& IL-8 has been also suggested as a tumor dependent possible mechanism influencing invasion and metastasis after anti-VEGF therapy. PBRM1 (BAF 180) mutation: Second major involved gene in clear cell RCC with truncating mutations in 41% (92/227) of cases. Mutations appear to inactive a protein that plays role in remodeling the structure of genetic material.PBRM1 mutations could be (partially) involved in about 40% of clear cell RCC. PBRM1 may affect the processes of cell divsion in renal cells and could consequently be another target for new drugs.
Study Type
OBSERVATIONAL
Enrollment
62
Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, Spain
Tissue and blood biomarkers
Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of progression free survival (PFS) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
Time frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
Tissue and blood biomarkers
Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of overal response rate (ORR) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
Time frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
Tissue and blood biomarkers
Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of overall survival (OS) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
Time frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
Tumor measure
Tumor measure according RECIST criteria
Time frame: Under Standar Clinical Practice (every 3 months)
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Hospital Universiario de León
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Hospital Gregorio Marañón
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Hospital Universitario Ramón y Cajal
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...and 2 more locations