Study Evaluating Renal Cell Carcinoma Risk Factors (MICRA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00927043
First received: June 22, 2009
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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 Intervention
Carcinoma, Renal Cell
Other: Epidemiological study according to clinical practice

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 145
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Epidemiological study according to clinical practice
Epidemiological study according to clinical practice.

Detailed Description:

invitation to volunteer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927043

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00927043     History of Changes
Other Study ID Numbers: 3066K1-4433, B1771010
Study First Received: June 22, 2009
Last Updated: November 4, 2011
Health Authority: Spain: Comite de Investigacion Clinica

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

ClinicalTrials.gov processed this record on October 22, 2014