Molecular Determinants for Therapy Response on Renal Cell Carcinoma

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Treatments: Bevacizumab; Everolimus; Sirolimus; Sunitinib

Criteria

Inclusion Criteria:

Minimum Age: 18 Years Maximum Age: no maximum age

• metastatic lesions easy of access for puncture for specimen storage

• histological subtype: clear-cell renal cancer

• no contraindications against systemic therapy

• indication for systemic therapy given

Exclusion Criteria:

• preexisting mental illness

• further active malignancy

• patients with increased risk of bleeding and/or wound healing disorder

• patients who are not legally competent or unable to consent

• contraindication for surgical intervention