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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic clear cell renal carcinoma (mRCC) patients | Metastatic clear cell renal carcinoma (mRCC) patients cadidates to receive Sunitinib 50 mg/day 4/2 schedule or Pazopanib 800mg/day until unaccetable toxicity or progression or death under standar clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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 | Under Standar Clinical Practice (every 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Metastatic clear cell renal carcionoma (mCCR) patients candidates to receive sunitinib or pazopanib under standard clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Emilio Esteban, MD. Phd. | Hospital Universitario Central de Asturias, Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain | ||
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| Label | URL |
|---|---|
| Spanish Oncology Genitourinary Group | View source |
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|
| Hospital Marqués de Valdecilla |
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital Universitario central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitarios de Burgos | Burgos | 09006 | Spain |
| Hospital Universiario de León | León | 24080 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28024 | Spain |
| Hospital Clínico (Madrid) | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| 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 |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| C516667 | pazopanib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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