NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

NCT01934452

CompletedN/A

Sponsor: Pfizer

Conditions: Complete Remission in Renal Cell Carcinoma

Interventions: sunitinib, sunitinib

Countries: France

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?)

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with metastatic renal cell carcinoma, histopathologically confirmed
* Treated with sunitinib according to Smpc
* For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
* For controls: Life expectancy \> 3 months No prior Sunitinib treatment
* Patient \>18 years

Exclusion Criteria:

* Sunitinib administered in a non-approved label
* For cases: CR occurring without sunitinib treatment
* For controls: Prior systemic treatment

Locations (14)

Marseille, Cedex 5, France
Strasbourg, Cedex, France
Angers, France
Brest, France
Le Mans, France
Marseille, France
Marseille, France
Marseille, France
Montpellier, France
Paris, France
Pierre-Bénite, France
Strasbourg, France
Vandœuvre-lès-Nancy, France
Villejuif, France