Actively Recruiting
Led by Niels Fristrup ยท Updated on 2026-05-04
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
N
Niels Fristrup
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
This research aims to understand how monitoring the levels of cancer treatment drugs in the blood can help improve outcomes for patients with metastatic renal cell carcinoma (mRCC). It focuses on how drug levels relate to treatment effectiveness and side effects, and also studies the role of antibodies and genetic variations in patients receiving checkpoint immunotherapy (CPI). The study also explores how the microbiome and certain gene polymorphisms may affect treatment response and survival. Patients with mRCC treated with drugs such as axitinib, cabozantinib, pazopanib, sorafenib, sunitinib, tivozanib, ipilimumab, and nivolumab will be observed. Blood samples will be collected regularly over six months for those on tyrosine kinase inhibitors (TKIs), while CPI-treated patients will have blood and stool samples taken from the start of treatment up to two years or until treatment failure. These samples will be analyzed for drug concentrations, antibodies, genetic markers, and microbiome characteristics. Participants will have various assessments including overall survival, progression-free survival, and quality of life measured using the FKSI-19 questionnaire over a 12-month follow-up. Researchers will track drug levels, antibody development, genetic variations, microbiome profiles, and circulating tumor DNA as markers of disease activity and treatment response. This observational study will follow Danish patients over a seven-year period to gather detailed data to better tailor treatments and improve patient care.
CONDITIONS
TDM for Optimized Outcome in Patients With mRCC.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed while receiving medical treatment for metastatic renal cell carcinoma with drugs including axitinib, cabozantinib, pazopanib, sorafenib, sunitinib, tivozanib, ipilimumab, and nivolumab. Blood samples and fecal swaps are collected to measure drug plasma concentrations, antidrug antibodies, genetic polymorphisms, microbiome composition, and circulating tumor DNA.
Blood samples and assessments at each clinical visit during treatment; fecal swaps during treatment; 12 months follow-up
Total: 1 location
1
Department of Oncology, Aarhus University Hospital
Aarhus, Danmark, Denmark, 8200
Actively Recruiting
N
Niels Fristrup, MD, PhD
J
Jakob N Henriksen, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Jakob N Henriksen, Charlotte U Andersen, Frede Donskov...
https://pubmed.ncbi.nlm.nih.gov/40457584