Clinical trial · Observational
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
NCT04712305CI-TRIAL-00056060recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention required | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.
- interventionNames
- Other: No intervention required
- label
- Cohort B
- description
- Validation cohort will be recruited in the next 36 months of the study period.
- interventionNames
- Other: No intervention required
Primary outcomes (5)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 7 years
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.