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

Metastatic Renal Cell Carcinoma Clinical Trial

— SOGANG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519542
• Other study ID #: SOG-ANG-2013-01
• Status: Completed
• Start date: November 2014
• Est. completion date: July 2018

Study information

• Verified date: April 2018
• Source: Spanish Oncology Genito-Urinary Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• Sunitinib
Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.

Locations

Country	Name	City	State
Spain	Hospital Universitarios de Burgos	Burgos
Spain	Hospital Universiario de León	León
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico (Madrid)	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Carlos Haya	Málaga
Spain	Hospital Universitario central de Asturias	Oviedo	Asturias
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Oncology Genito-Urinary Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Tumor measure	Tumor measure according RECIST criteria	Under Standar Clinical Practice (every 3 months)

External Links

•   Spanish Oncology Genitourinary Group