kidney cancer Renal cell cancer
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with advanced (unresectable and/or metastatic) renal cell cancer; • Patients who will start treatment with sunitinib, pazopanib, sorafenib, axitinib or everolimus; • At least one tumor lesion should be accessible for biopsy. Bone metastases are excluded as possible biopsy site; • Age >- 18 years; • Patients must have at least one measurable lesion. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST); • WHO performance status 0 - 2; • Able to provide written informed consent;
Exclusion criteria
Exclusion criteria: • Clinical findings associated with an unacceptably high tumor biopsy risk, according to the judgement of the investigator; • Radiotherapy on target lesions during study or within 4 weeks of the start of study drug; • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pretreatment tumor tissue phosphoproteomic profile, radiological response to standard treatment, PFS. Phosphoproteomic profiles will be determined from the tumor biopsy and correlated to radiological response and PFS. Phosphotyrosine signaling pathways aberrantly activated in individual subgroups, identified by unsupervised hierarchical clustering, will be examined in relation to the clinical effect of the different kinase inhibitors. The classifier will be based on activity of one or multiple signaling pathways and protein networks and will be subjected to an internal validation such as the ten-fold cross validation technique to estimate its generalization performance. Primary endpoint: Prediction accuracy of the phosphoproteomic classifier | — |
Secondary
| Measure | Time frame |
|---|---|
| -To determine the relation between pre-treatment PamChip kinase activity profiling and PFS -To determine whether genome-wide mutational profiles by Massively Parallel Sequencing (MPS) can be related to PFS -To determine whether both pre- and on-treatment serum proteomic profiles are related to PFS -To determine the value of the frequency and phenotype of immunoregulatory cells in blood and tumor tissue for treatment response prediction. -To determine the relation between genetic polymorphisms and pharmacokinetic parameters (systemic and intratumoral drug concentrations) and PFS. -To determine the value of tumor exosomes from urine and serum as potential source of biomarkers. | — |
Countries
Netherlands
Outcome results
None listed