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Spots Global Cancer Trial Database for Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

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Trial Identification

Brief Title: Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

Official Title: Prospective Study of Complete Remissions Observed With Sunitinib in Patients With Metastatic Renal Cell Carcinoma mRCC)

Study ID: NCT01934452

Interventions

sunitinib
sunitinib

Study Description

Brief Summary: This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions : Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

Detailed Description: The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission. The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling. A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%. The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU de la Timone, Marseille, Cedex 5, France

CHU Strasbourg, Strasbourg, Cedex, France

CHRU HOTEL DIEU - Service Urologie, Angers Cedex, , France

C.H.U Morvan, Brest, , France

Clinique Victor Hugo, Le Mans, , France

Institut Paoli-Calmettes, Marseille Cedex 09, , France

Institut Paoli-Calmettes / Hôpital de jour, Marseille Cedex 9, , France

Hopital Timone Adultes, Marseille Cedex, , France

CRLC Val d'Aurelle, Montpellier cedex 05, , France

Hopital Europeen Georges Pompidou, Paris Cedex 15, , France

Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France

Clinique Chirurgicale de l'Orangerie, Chiliotherapie, Strasbourg, , France

Centre Alexis Vautrin, Vandoeuvre les Nancy, , France

Institut Gustave Roussy, Villejuif Cedex, , France

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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