Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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?)

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib

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