drugset / Trial / NCT02208128

Molecular Determinants for Therapy Response on Renal Cell Carcinoma

NCT02208128

Unknown 4 enrolled Heidelberg University
NaSingle-groupOpen-labelTreatment

Summary

Aim of the scientific analysis is to find biological factors (biomarkers) allowing a prediction of disease progression and a better choice of therapy. After diagnosis the kidney and the tumor will be removed by standard surgery followed by drug therapy. Within surgery remaining tumor tissue will be used for the scientific analysis. In case of disease progression during the drug treatment the drug therapy will be changed. Before therapy change a small tissue sample will be collected for molecular diagnostics. This will be done by puncture through the skin under local anesthesia. Blood samples taken before surgery and at the time of first and second disease progression will also be used for molecular-biological analysis. As there is no clear recommendation for drug therapy after disease progression this study should serve to determine an individual therapy on the basis of the molecular profile and the molecular changes. As the tumor disease changes and developes resistance to drugs, analysis at the time of disease progression shall identify biological factors which will predict a likelihood response to a specific drugs. This shall allow to give the patient an individual therapy.

Timeline

Start
2014-05
Primary completion
2018-02
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody
Comparator Everolimus Small molecule
Comparator Pazopanib Small molecule
Comparator Sunitinib Small molecule

Indications