NCT04712305Recruiting
Urine Omics Predicting IO Therapy Responses in mRCC 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
Source: ClinicalTrials.gov · Last updated 20 Jan 2022 · 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 renal cell carcinoma.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 13 Jan 2021
- Start date
- Jan 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT04712305
What you commit to
- Study type: Observational
- Planned participants: 400
- From Jan 2021 to the primary completion date, Dec 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
- 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.
Other illness
- 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.
Lab values
- Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
Other
- Subjects NOT willing to sign the informed consent form
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page 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.