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Tumor-derived circulating endothelial cells as a biomarker in locally advanced and metastatic clear cell renal cell carcinoma

Conditions
clear cell renal cell carcinoma
kidney cancer
10038364
Registration Number
NL-OMON45737
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

* Patients with locally advanced or metastatic ccRCC
* Candidate for receiving first-line therapy with sunitinib or pazopanib
* Age * 18 years
* Written informed consent

Exclusion Criteria

* Serious illness or medical unstable condition prohibiting adequate treatment and follow-up
* Previous treatment with systemic therapy for ccRCC

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint is to explore if the presence of CD276-positive CECs in<br /><br>locally advanced or metastatic ccRCC patients before the start of VEGFR-TKI<br /><br>based therapy, is worth more investigation. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are to explore whether a CEC count * 8 CD276-positive CECs<br /><br>for start of the therapy is associated with the PFS at 12 months. Furthermore,<br /><br>we will explore if changes in the CD276-positive CEC count measured 4 weeks<br /><br>after start of first-line VEGFR-TKI based therapy are associated with the PFS<br /><br>at 12 months.</p><br>
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