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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45737

Enrollment

Registered

2016-10-25

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clear cell renal cell carcinoma kidney cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is to explore if the presence of CD276-positive CECs in locally advanced or metastatic ccRCC patients before the start of VEGFR-TKI based therapy, is worth more investigation.	—

Secondary

Measure	Time frame
Secondary endpoints are to explore whether a CEC count * 8 CD276-positive CECs for start of the therapy is associated with the PFS at 12 months. Furthermore, we will explore if changes in the CD276-positive CEC count measured 4 weeks after start of first-line VEGFR-TKI based therapy are associated with the PFS at 12 months.	—

Countries

Netherlands

Outcome results