Clinical trial NCT03519542: Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic clear cell renal carcionoma (mCCR) patients candidates to receive sunitinib or pazopanib under standard clinical practice

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tissue and blood biomarkers
timeFrame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
measure: Tissue and blood biomarkers
timeFrame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
measure: Tissue and blood biomarkers
timeFrame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
measure: Tumor measure
timeFrame: Under Standar Clinical Practice (every 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Burgos
country: Spain
facility: Hospital Universitarios de Burgos
city: León
country: Spain
facility: Hospital Universiario de León
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico (Madrid)
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Hospital Universitario Central de Asturias, Spain.
name: Emilio Esteban, MD. Phd.
role: PRINCIPAL_INVESTIGATOR
References: