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Urine Tests to Predict Response to Immunotherapy in Kidney Cancer

Studies urine markers that may predict treatment effects in advanced kidney cancer patients.

Plain-language title generated from the registry record
Registry title: Urine Omics Predicting IO Therapy Responses in mRCC Patients

Key facts

Where
Taipei, TaiwanSee the site

Where in Taiwan

  • National Taiwan University HospitalTaipei, TaiwanTaking people

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Trial details

Who runs it
National Taiwan University Hospital
Trial code
NCT04712305
Record updated
20 January 2022
Original description
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.Read full original descriptionShow less

Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma

The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.

Inclusion: Age > 20 years; Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC); Subjects who are about to receive IO-based therapy; ECOG performance 0, 1, 2, and 3; Life expectancy >3 months; eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better); Willing to sign the informed consent form.

Exclusion: Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators; Subjects who have taken any IO-based therapy before; Subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >4 weeks are allowed to enroll. Subjects who have received or are receiving targeted therapy are allowed to join the study; Subjects having co-existing other malignancies that need active treatment. Those subjects with other malignancies that do not need active treatment are allowed to join the study; Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF; Subjects NOT willing to sign the informed consent form.

ClinicalTrials.gov NCT04712305