Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma
- Registration Number
- NCT03519542
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Locally avanced or metastatic renal cell carcinoma with clear-cell component histology candidates to recieve sunitinib or pazopanib in fisrt line under standard clinical practice.
- Measurable disease by CT or MRI
- Life expectancy >3 months
- Written informed consent.
- Performance Status 0-2
- Any patients who does not fulfill the inclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Metastatic clear cell renal carcinoma (mRCC) patients Sunitinib 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.
- Primary Outcome Measures
Name Time Method Tissue and blood biomarkers 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. 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).Tumor measure Under Standar Clinical Practice (every 3 months) Tumor measure according RECIST criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Hospital Universiario de Le贸n
馃嚜馃嚫Le贸n, Spain
Hospital Cl铆nico Universitario de Santiago de Compostela
馃嚜馃嚫Santiago de Compostela, A Coru帽a, Spain
Hospital Marqu茅s de Valdecilla
馃嚜馃嚫Santander, Cantabria, Spain
Hospital Gregorio Mara帽贸n
馃嚜馃嚫Madrid, Spain
Hospital Universitarios de Burgos
馃嚜馃嚫Burgos, Spain
Hospital Universitario central de Asturias
馃嚜馃嚫Oviedo, Asturias, Spain
Hospital 12 de Octubre
馃嚜馃嚫Madrid, Spain
Hospital Universitario Ram贸n y Cajal
馃嚜馃嚫Madrid, Spain
Hospital Cl铆nico (Madrid)
馃嚜馃嚫Madrid, Spain
Hospital Universitario La Paz
馃嚜馃嚫Madrid, Spain
Hospital Universitario Carlos Haya
馃嚜馃嚫M谩laga, Spain
Hospital Cl铆nico Lozano Blesa
馃嚜馃嚫Zaragoza, Spain