Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma
SOGANG
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
1 other identifier
observational
62
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 18, 2019
April 1, 2018
2.1 years
October 29, 2014
September 17, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
Tumor measure
Tumor measure according RECIST criteria
Under Standar Clinical Practice (every 3 months)
Study Arms (1)
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.
Interventions
Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.
Eligibility Criteria
Metastatic clear cell renal carcionoma (mCCR) patients candidates to receive sunitinib or pazopanib under standard clinical practice
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitarios de Burgos
Burgos, 09006, Spain
Hospital Universiario de León
León, 24080, Spain
Hospital Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28024, Spain
Hospital Clínico (Madrid)
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Clínico Lozano Blesa
Zaragoza, 50009, Spain
Related Links
Biospecimen
* Serum Biomarkers * Peripheral Blood * Tissue Biomarkers (FFEP tumor tissue from filed tissue sample, protein expresion will be assesed by IHC)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilio Esteban, MD. Phd.
Hospital Universitario Central de Asturias, Spain.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
May 9, 2018
Study Start
November 1, 2014
Primary Completion
December 1, 2016
Study Completion
July 1, 2018
Last Updated
September 18, 2019
Record last verified: 2018-04