on-interventional study on Therapeutic Drug Monitoring (TDM) in patients with renal cell carcinoma and on the feasibility of using Volumetric Absorptive Microsampling (VAMS) for sample collection (ON-TARGET)
Recruiting
- Conditions
- C64Malignant neoplasm of kidney, except renal pelvis
- Registration Number
- DRKS00025325
- Lead Sponsor
- Central European Society for Anticancer Drug Research (CESAR) e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Patients who are being treated with either axitinib or cabozantinib, who have full legal capacity and are linguistically, physically and mentally capable of completing the patient questionnaire independently, and who have provided written informed consent.
Exclusion Criteria
Patients with insufficient knowledge of the German language.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study objective is to prospectively gain evidence on the potential of a routine TDM to reduce the frequency and severity of adverse drug events compared with the frequency and severity of adverse drug events in historical controls (extracted from literature) in patients receiving oral tumor therapy.
- Secondary Outcome Measures
Name Time Method -To gain insight into the potential of a routinely performed therapeutic drug monitoring to identify (i) the existence of patient subgroups with a particularly high incidence of and/or particularly high severity of adverse drug reactions, and (ii) plasma concentration thresholds that should not be exceeded for acceptable toxicity<br><br>-To investigate the practicality of the VAMS technology for TDM sample collection<br><br>-Development and establishment of a nationwide infrastructure for the implementation of TDM for oral anticancer drugs