The primary objective is to explore if the presence of CD276-positive CECs in locally advanced or metastatic ccRCC patients treated with systemic therapy is worth more investigation. Furthermore, the clinical value of CD276-positive CECs will be…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Renal cell carcinoma accounts for 2-3% of the malignancies in adults worldwide.
70-80% of the malignant solid lesions in 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 CEC 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 or metastatic ccRCC.
Study objective
The primary objective is to explore if the presence of CD276-positive CECs in
locally advanced or metastatic ccRCC patients treated with systemic therapy is
worth more investigation. Furthermore, the clinical value of CD276-positive
CECs will be explored.
Study design
multi-center prospective, open study.
Study burden and risks
in all patients, 2x 10 mL blood for CEC enumeration and characterization will
be drawn during another blood draw that is already required for standard care.
Therefore, no risks are associated with participation in this study.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58598.078.16 |
| OMON | NL-OMON25402 |