Identifying urine markers to predict responses to immunotherapy in kidney cancer patients
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma
National Taiwan University Hospital · NCT04712305
This study is trying to find out if certain substances in urine can help predict how well immunotherapy will work for people with advanced kidney cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04712305 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with metastatic renal cell carcinoma (mRCC) who are about to receive immuno-oncology (IO) therapies. Participants will provide fresh urine samples for analysis using advanced metabolomics and proteomics techniques to identify biomarkers that can predict treatment efficacy and potential side effects. The study aims to enhance personalized treatment approaches by understanding how these urinary markers correlate with patient responses to therapy. It is a multi-center, single-arm study that does not involve any direct interventions.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with advanced or metastatic renal cell carcinoma who are about to start immuno-oncology therapy.
Not a fit: Patients who have previously received immuno-oncology therapy or those with active infections may 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 the approach of using urinary biomarkers in cancer treatment is being explored, this specific study's focus on mRCC and IO therapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 20 years 2. Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC) 3. Subjects who are about to receive IO-based therapy 4. ECOG performance 0, 1, 2, and 3 5. Life expectancy \>3 months 6. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better) 7. Willing to sign the informed consent form Exclusion Criteria: 1. Subjects NOT willing to sign the informed consent form 2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF 3. 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. 4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators 5. Subjects who have taken any IO-based therapy before. 6. 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.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Yeong Shiau Pu, MD PhD
- Email: pu5249@ntuh.gov.tw
- Phone: 886-2-23123456
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.
Conditions: Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma, biomarkers, clinical responses, IO-based therapies, metabolomics, proteomics, Urine