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Study Evaluating Renal Cell Carcinoma Risk Factors (MICRA)

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ClinicalTrials.gov Identifier: NCT00927043
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment
Carcinoma, Renal Cell Other: Epidemiological study according to clinical practice

Detailed Description:
invitation to volunteer

Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1 Other: Epidemiological study according to clinical practice
Epidemiological study according to clinical practice.



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Response rate. [ Time Frame: 12 months ]
  2. Overall survival. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment naive patients with proven advanced RCC
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927043


Locations
Spain
Pfizer Investigational Site
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00927043     History of Changes
Other Study ID Numbers: 3066K1-4433
B1771010
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases