NCT00927043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

June 22, 2009

Last Update Submit

November 4, 2011

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    12 months

Secondary Outcomes (2)

  • Response rate.

    12 months

  • Overall survival.

    12 months

Study Arms (1)

1

Other: Epidemiological study according to clinical practice

Interventions

Epidemiological study according to clinical practiceOTHER

Epidemiological study according to clinical practice.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treatment naive patients with proven advanced RCC

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations

ES(1)