NCT03519542

Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma

Muticentric and Prospective Epidemiological Study to Identify Prognosis and Predictive Biomarkers of Response to Angiogenic Drugs Approved in First Line of Treatment for Advanced or Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib	Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-01
• Completion: 2018-07-01
• First posted: 2018-05-09
• Last updated: 2019-09-18

Locations

12 sites across 1 country: Spain