Identifying urine markers to predict responses to immunotherapy in bladder cancer patients
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
This study is testing if certain markers in urine can help predict how well immunotherapy will work for people with advanced bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | enfortumab, chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04641936 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with metastatic urothelial carcinoma (mUC) 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 diagnosed with metastatic urothelial carcinoma who are about to start IO-based therapy.
Not a fit: Patients who have previously received any IO-based 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 urothelial carcinoma.
How similar studies have performed: While similar studies exploring biomarkers in cancer treatment have shown promise, this specific approach focusing on urinary markers in mUC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age \> 20 years * 2\. Subjects diagnosed as metastatic urothelial carcinoma (mUC) * 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 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 CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll. * 6\. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \>12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yeong Shiau Pu, MD PhD — Department of Urology, National Taiwan University Hospital
- 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.