Monitoring drug levels to improve outcomes in metastatic kidney cancer patients
Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma
This study is testing how monitoring drug levels and certain genetic factors can help improve treatment outcomes for people with metastatic kidney cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | immunotherapy, ipilimumab, nivolumab |
| Locations | 1 site (Aarhus, Danmark) |
| Trial ID | NCT04659343 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and side effects of treatment drugs in patients with metastatic renal cell carcinoma (mRCC) by monitoring plasma drug concentrations. It also investigates the role of anti-drug antibodies and genetic variations in CTLA-4 and PD-1 receptors that may contribute to treatment failure. Additionally, the study will explore correlations between UGT1A1 gene polymorphisms and pazopanib dosing. The goal is to optimize treatment regimens and identify patients who may not benefit from certain therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients in Denmark who are being medically treated for metastatic renal cell carcinoma.
Not a fit: Patients who are unable to provide written informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic renal cell carcinoma.
How similar studies have performed: While some studies have explored plasma concentration monitoring in cancer treatments, this specific approach focusing on mRCC and the associated genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients in Denmark with medically treated metastatic renal cell carcinoma. Exclusion Criteria: * No written informed consent.
Where this trial is running
Aarhus, Danmark
- Department of Oncology, Aarhus University Hospital — Aarhus, Danmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Niels Fristrup, MD, PhD — University of Aarhus
- Study coordinator: Niels Fristrup, MD, PhD
- Email: niels.fristrup@rm.dk
- Phone: +4520914161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.