NCT04641936Recruiting
Urine Omics Predicting IO Therapy Responses in mUC Patients
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
Source: ClinicalTrials.gov · Last updated 17 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 urothelial carcinoma.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 18 Nov 2020
- Start date
- 17 Dec 2020
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT04641936
What you commit to
- Study type: Observational
- Planned participants: 600
- From 17 Dec 2020 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 2\. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
Other
- 1\. Subjects NOT willing to sign the informed consent form
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.