Metastatic Renal Cell CarcinomaSOGANGNCT03519542
Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma
An observational study of Metastatic Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sunitinib
- How many people
- 62 participants
- Where
- 12 sitesSpain
- Study dates
- Nov 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic clear cell renal carcionoma (mCCR) patients candidates to receive sunitinib or pazopanib under standard clinical practice
Who may be able to join
- 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
Who cannot join
- Any patients who does not fulfill the inclusion criteria.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Universitarios de Burgos
Burgos, 09006
Hospital Universiario de León
León, 24080
Hospital Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28024
Hospital Clínico (Madrid)
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid
Hospital Universitario Carlos Haya
Málaga, 29010
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Clínico Lozano Blesa
Zaragoza, 50009
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sunitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Pazopanib
Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Under Standar Clinical Practice (every 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study startNov 2014
- Primary completionDec 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilio Esteban, MD. Phd., Principal investigator, Hospital Universitario Central de Asturias, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519542
- Sponsor's protocol ID
- SOG-ANG-2013-01
- Acronym
- SOGANG
- Status last verified
- Apr 2018
- First submitted
- 29 Oct 2014
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03519542
- Acronym / sponsor ID
- SOGANG / SOG-ANG-2013-01
- Conditions
- Metastatic Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic clear cell renal carcinoma (mRCC) patients | – | Drug: SunitinibMetastatic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic clear cell renal carcionoma (mCCR) patients candidates to receive sunitinib or pazopanib under standard clinical practice
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any patients who does not fulfill the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunitinibAlso: PazopanibIdentify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma. | Drug | Metastatic clear cell renal carcinoma (mRCC) patients |
Primary outcome
Tissue and blood biomarkers
Time frame: 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 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).
Tissue and blood biomarkers
Time frame: 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 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).
Tissue and blood biomarkers
Time frame: 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
Time frame: Under Standar Clinical Practice (every 3 months)
Tumor measure according RECIST criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Spanish Oncology Genitourinary GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Esteban, MD. Phd. principal investigator
Hospital Universitario Central de Asturias, Spain.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue and blood biomarkers (time frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.