Study Evaluating Renal Cell Carcinoma Risk Factors (MICRA)
November 4, 2011 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
invitation to volunteer
Study Type
Observational
Enrollment (Actual)
145
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Treatment naive patients with proven advanced RCC
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
|
Epidemiological study according to clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free survival
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Response rate.
Time Frame: 12 months
|
12 months
|
|
Overall survival.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimate)
June 24, 2009
Study Record Updates
Last Update Posted (Estimate)
November 6, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3066K1-4433
- B1771010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.