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

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Sunitinib

• 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.

Study Timeline

• Study First Submitted: 2014-10-29
• Study Start: 2014-11
• Primary Completion: 2016-12
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-09
• Study Completion: 2018-07
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Trial Locations

Locations (12)

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital Universitario central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitarios de Burgos; 🇪🇸 Burgos, Spain

Hospital Universiario de León; 🇪🇸 León, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico (Madrid); 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

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