Carcinoma, Renal CellMICRANCT00927043
Study Evaluating Renal Cell Carcinoma Risk Factors
An observational study of Carcinoma, Renal Cell, run by Pfizer at 1 site in Spain.
Trial summary
This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Epidemiological study according to clinical practice
- How many people
- 145 participants
- Where
- 1 siteSpain
- Study dates
- May 2009to Sep 2011
- 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: Treatment naive patients with proven advanced RCC
Who may be able to join
- Treatment naïve patients with proven advanced RCC will be evaluated. (Except surgery or radiotherapy)
- =18 years, any gender.
- Patients with advanced Renal Cell Carcinoma and treatment naïve.
Who cannot join
- Patients who have already initiated any kind of specific therapy for the treatment of RCC.2.
- Patients with other neoplasias different from RCC (current or past).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter, Epidemiological Study To Determine The Clinical, Molecular And Genetic Factors Associated To The Prognosis Of Patients With Advanced Renal Cell Carcinoma
This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.
Read the detailed description
invitation to volunteer
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Epidemiological study according to clinical practice
- 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.
Epidemiological study according to clinical practiceOther
Epidemiological study according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Epidemiological study according to clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 12 months
Secondary outcomes (2)
Response rate.
Measured: 12 months
Overall survival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927043
- Sponsor's protocol ID
- 3066K1-4433
- Other IDs
- B1771010
- Acronym
- MICRA
- Status last verified
- Nov 2011
- First submitted
- 22 Jun 2009
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Epidemiological Study To Determine The Clinical, Molecular And Genetic Factors Associated To The Prognosis Of Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00927043
- Acronym / sponsor ID
- MICRA / 3066K1-4433
- Conditions
- Carcinoma, Renal Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Jun 2009 (estimated)
- 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.
This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.
Detailed description
invitation to volunteer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Epidemiological study according to clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naive patients with proven advanced RCC
Key inclusion criteria (3 listed)
- Treatment naïve patients with proven advanced RCC will be evaluated. (Except surgery or radiotherapy)
- =18 years, any gender.
- Patients with advanced Renal Cell Carcinoma and treatment naïve.
Key exclusion criteria (2 listed)
- Patients who have already initiated any kind of specific therapy for the treatment of RCC.2.
- Patients with other neoplasias different from RCC (current or past).
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 |
|---|---|---|
| Epidemiological study according to clinical practiceEpidemiological study according to clinical practice. | Other | 1 |
Primary outcome
Progression-free survival
Time frame: 12 months
2 secondary outcomes
Response rate.
Time frame: 12 months
Overall survival.
Time frame: 12 months
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 7 Nov 2011.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by Pfizer at 1 site 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 3 inclusion and 2 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 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Progression-free survival (time frame: 12 months). 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 7 Nov 2011.