No registrations found.
ID
Source
Brief title
Health condition
Clear cell renal cell carcinoma, endothelial cell, metastatic disease, VEGFR-TKI
Sponsors and support
Intervention
Outcome measures
Primary outcome
The value of CD276-positive CECs in locally advanced or metastatic clear cell renal cell caricnoma before start VEGFR-TKI based therapy
Secondary outcome
- The association of CD276-positive CEC count in locally advanced or metastatic clear cell renal cell carcinoma with PFS at 12 months
- The association of changes after 4 weeks of VEGFR-TKI treatment in CD276-positive CEC count in locally advanced or metastatic clear cell renal cell carcinoma with PFS at 12 months
Background summary
Renal cell carcinoma accounts for 2-3% of the malignancies in adults worldwide. 70-80% of the malignant solid lesions of the kidney are clear cell renal cell carcinomas (ccRCC). With ccRCC being relatively chemotherapy and radiotherapy resistant, targeted therapies are the therapies of choice in ccRCC when treatment is indicated. No sensitive biomarkers are available to determine the response of these targeted therapies. Since all of the first-line targeted therapies exert anti-angiogenic effects, circulating endothelial cells (CECs) can fulfill a role in this need for biomarkers. CECs are endothelial cells that are shed from the vessel wall. Recently, we identified a marker (CD276) that can distinguish between CECs that originate from the normal vasculature (CD276-negative) and the tumor vasculature (CD276-positive) in patients. Also, studies have shown that 95-98% of the immunohistochemically stained ccRCC vasculature specimens are positive for CD276 and that diffuse vascular CD276-expression was associated with poor outcome. Therefore, we hypothesize that CD276-positive CECs can be of clinical value in patients with locally advanced metastatic ccRCC.
Study objective
We hypothesize that CD276-positive CECs can be of clinical value in patients with locally advanced or metastatic ccRCC
Study design
- CD276-positive CEC count at baseline and after 4 weeks of VEGFR-TKI based therapy
- PFS at 12 months
Intervention
Blood draw at baseline and after 4 weeks
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
Inclusion criteria
- Patients with locally advanced or metastatic clear cell renal cell carcinoma
- 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 clear cell renal cell carcinoma
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7058 |
NTR-old | NTR7296 |
CCMO | NL58598.078.16 |
OMON | NL-OMON45737 |