Clinical trial · Observational
TDM for Optimized Outcome in Patients With mRCC.
Therapeutic Drug Monitoring for Optimized Outcome in Patients With Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects. It furthermore holds microbiome characterization of CPI-treated patients. Furthermore, the investigators examines the role of anti-drug antibodies and receptor polymorphisms in CTLA-4 and PD-1 receptors in treatment failure among patients with mRCC treated with check point immunotherapy (CPI). Moreover, polymorphisms in the UGT1A1 gene will be correlated with the pazopanib treatment dose.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Mechanism | — | UNRESOLVED | — |
| Drug Side Effect | — | UNRESOLVED | — |
| Drug Toxicity | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measurement of concentration of active metabolite in cancer treatment. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Patients treated for metastatic renal cell carcinoma in Denmark over a 6-year period.
- interventionNames
- Other: Measurement of concentration of active metabolite in cancer treatment.
Primary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- 12 months follow-up for each patient.
- description
- Calculated from the date of inclusion, to the date of death of any cause or censored at the date at last follow-up.
- measure
- Progression free survival (PFS)
- timeFrame
- 12 months follow-up for each patient.
- description
- According to the RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients in Denmark with medically treated metastatic renal cell carcinoma. Exclusion Criteria: * No written informed consent.
References
Publications (1)
- DERIVEDHenriksen JN, Andersen CU, Donskov F, Hoffmann-Lucke E, Greibe E, Fristrup N. Therapeutic drug monitoring (TDM) of tyrosine kinase inhibitors (TKI) for optimized outcome in patients with metastatic renal cell carcinoma. The TKI-TDM Trial. Study protocol. Acta Oncol. 2025 Jun 2;64:729-733. doi: 10.2340/1651-226X.2025.43693. PMID 40457584