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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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

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Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metastatic clear cell renal carcinoma (mRCC) patients

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.

Sunitinib

Intervention Type DRUG

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

Interventions

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Sunitinib

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

Intervention Type DRUG

Other Intervention Names

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Pazopanib

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No