Table 4.
Currently ongoing clinical trials focused on liquid biomarkers in renal cell carcinoma
| NCT Number | Liquid biopsy component | Study Name | Type | Country and number of patients | Recruiting Status | Brief summary |
|---|---|---|---|---|---|---|
| NCT04883827 | CfDNA | Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer | Observational | United States;150 | Recruiting | This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy |
| NCT04197414 | ctDNA | Development of Urologic Registry for Personalized Medicine in Patients with Urological Malignancy by Analyzing Circulating Tumor DNA | Observational | Korea; 3000 | Recruiting | This study aims to explore the usefulness of ctDNA in plasma and urine for the detection of urologic malignancies, the monitoring of disease progression and the assessment of treatment response |
| NCT05059444 | ctDNA | ORACLE: Observation of Residual Cancer with Liquid Biopsy Evaluation | Observational | United States; 1000 | Recruiting | This study aims to demonstrate the ability of a new ctDNA assay developed by Guardant Health to early detect recurrence in patients with solid tumors (including RCC) |
| NCT03702309 | cfDNA; cfRNA | Liquid Biopsy Evaluation and Repository Development at Princess Margaret | Observational | Canada; 2500 | Recruiting | This study aims to use circulating cell-free nucleic acids, including cfDNA and cfRNA, as a means to non-invasively assess multiple tumor progression and treatment response at multiple time points in a patient's disease course |
| NCT04891055 | CTC; miRNAs | Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated with Nivolumab (I-Rene Trial) | Observational | Italy; 90 | Recruiting | The study aims to evaluate whether circulating miRNAs or CTCs may be a potential predictor of clinical response and disease progression in metastatic RCC patients treated with Nivolumab |
| NCT03667885 | DNA and mRNAs | Non-Invasive Diagnostics of Small Renal Masses | Observational | Denmark; 160 | Recruiting | Studies 1 and 2 were designed to look for circulating biomarkers in the form of DNA and mRNA contained in microvesicles secreted into the blood by RCCs and to find changes in biomarker levels after surgery |
| NCT04946266 | LncRNA-MFI2-AS1 | Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers | Observational | France; 260 | Recruiting | This study aims to detect the expression of LncRNA-MFI2-AS1 in the plasma of Localized Clear Cell Kidney Cancers to explore its use as a biomarker for pre-tissue analysis diagnosis and patient follow-up |
| NCT04053855 | Urinary exosomes | Evaluation of Urinary Exosomes Presence from Clear Cell Renal Cell Carcinoma | Observational | France; 100 | Recruiting | This study aims to develop a reliable technique to detect tumor exosomes in the urine of ccRCC patients and to provide a new liquid biopsy tool for their early diagnosis |
| NCT05060783 | Glycosaminoglycans | Renal Cancer Detection with Liquid Biopsy | Observational | Denmark; 200 | Recruiting | This study aims to explore the diagnostic role of alterations in plasma and urine glycosaminoglycans for RCC |
| NCT03628859 | Intracellular cytokines | BIOREN (Predictive BIOmarkers in Metastatic RENal Cancer)—A Translational Study on Immunotherapy for Metastatic Renal Cancer | Observational | France; 30 | Recruiting | This study aims to characterize the genetic background of RCCs and their immune environment, to try and identify biomarkers of response and to better understand the mechanisms of resistance to nivolumab in RCC |
| NCT03185039 | MMP2 and MMP9 | Predictive Impact of MMP2 and MMP9 Levels for Patients with Metastatic Kidney Cancer Treated with Anti-angiogenic Agents | Interventional | France; 50 | Recruiting | This study aims to explore plasma levels of MMP2 and MMP9 as predictive biomarkers for treatment with 2 anti-angiogenic drugs (sunitinib or pazopanib) in patients with metastatic kidney cancer |
| NCT05214885 | CA9、NDUFA4L2、ANGPTL4、HILPDA and EGLN3 | Novel Biomarkers of Hypoxia and Metabolism in Clear Cell Renal Cell Carcinoma | Observational | China; 300 | Recruiting | This study aims to detect mRNA and protein levels of five hypoxia- and metabolism-related molecules in blood or urine samples to explore specific tumor biomarker profiles for clinical diagnosis, assessment of ccRCC recurrence, metastasis and prognosis |
| NCT04113486 | NMAP | Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations | Observational | China; 400 | Recruiting | This study aims to observe the difference between NMAP serum levels in primary diagnosed RCC patients and controls and to plot the ROC curve and establish appropriate cut-off values |
| NCT05285579 | Immune-related circulating biomarkers | Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic | Observational | France; 100 | Not yet recruiting | This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced RCC treated by a combination of immunotherapy and antiangiogenic |
| NCT04006405 | Glycosaminoglycans | AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥ 5 Non-metastatic Clear Cell Renal Cell Carcinoma | Observational | United States; 280 | Recruiting | This is an observational prospective, multicenter, diagnostic test cohort study which aims to predict disease recurrence in non-metastatic ccRCC using glycosaminoglycans scores in blood and urine |
| NCT04712305 | Metabolomics and Proteomics | Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma | Observational | Taiwan; 400 | Recruiting | The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving Immuno-Oncology-based therapies for metastatic RCC |
| NCT05112627 | Serum immune markers | Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy | Observational | United States; 45 | Recruiting | This study aims to evaluate serum immune markers and peripheral blood mononuclear cell characteristics in patients with metastatic RCC treated with SBRT or PCA, and the impact on their overall distant disease progression |