Clinical trial · Observational
Urothelial Tumor Risk Genes Detection With Genetron Uro V1 and LC-WGS
A Study of the Urine Non-invasive Liquid Biopsy in Diagnosis and Recurrence Diagnosis of Urothelial Carcinoma
- 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)
Genetron Uro V1 perform mutation detection of 17 genes and methylation detection of 1 gene by using urine samples and tumor tissue samples. It is a urine liquid biopsy method that has a great supplementary effect on the existing clinical differential diagnosis technology. The main aim of this study is to compare the test results of Genetron Uro V1 with the standard clinical diagnosis results, and analyze the performance of Genetron Uro V1 in the diagnosis and recurrence diagnosis of urothelial 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 |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study only - no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Diagnosis group of patients with urothelial cancer
- description
- Patients with painless intermittent gross hematuria during outpatient/emergency/hospitalization diagnose as urothelial carcinoma in this study will be assigned to this group
- interventionNames
- Other: Observational study only - no intervention
- label
- Diagnosis group of patients with benign urinary diseases
- description
- Patients with painless intermittent gross hematuria during outpatient/emergency/hospitalization diagnose as benign urinary diseases in this study will be assigned to this group
- interventionNames
- Other: Observational study only - no intervention
- label
- Recurrence diagnosis group with urothelial cancer
- description
- Patients who were diagnosed with non-muscle invasive urothelial carcinoma and diagnosed as recurrent urothelial carcinoma in this study will be assigned to this group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Diagnosis Group: 1. Randomly enrolled hematuria patients in outpatient/emergency/inpatient care 2. Gender is not limited 3. Age ≥18 years old 4. Able to provide 100ml urine sample before cystoscopy 5. At the same time, the following requirements still need to be met: 1\) Agree to provide personal basic clinical information, pathology and imaging data for scientific research, and sign scientific research-related informed consent 2) Agree to conduct genetic testing services involved in the trial Recurrence diagnosis group: 1\. A patient diagnosed with non-muscular invasive urothelial carcinoma 2. Follow the guidelines for routine recurrence monitoring standard programs 3. No gender limit 4. Age ≥18 years old 5. All urothelial tumors have been surgically removed 6. Agree to perform cystoscopy and urine exfoliation cytology for each recurrence monitoring 7. At the same time, the following requirements still need to be met: 1. Agree to provide personal basic clinical information, pathology and imaging data for scientific research, and sign scientific research-related informed consent; agree to conduct genetic testing services involved in the trial 2. Agree to conduct genetic testing services involved in the experiment - Exclusion Criteria: Diagnosis group: 1. Patients with other non-urothelial malignancies (including prostate cancer and renal cell carcinoma) 2. Patients with secondary urothelial tumors 3. Patients who cannot undergo cystoscopy and urine exfoliative cytology 4. Samples with incomplete pathological information, and samples with positive case information that cannot clarify the pathological results and tumor staging 5. Contaminated samples 6. Patients whose urine samples fail to pass the quality control due to reasonable reasons and cannot be sampled again 7. Samples that cannot be tested due to reasonable reasons 8. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements 9. Patients who cannot provide written informed consent Recurrence diagnosis group: 1. Patients with other non-urothelial malignancies (including prostate cancer and renal cell carcinoma) 2. Patients who cannot undergo cystoscopy and urine exfoliative cytology 3. Patients planning to undergo cystectomy/neoadjuvant chemotherapy/radiotherapy 4. Patients who have been enrolled at the pre-recurrence monitoring time point 5. Samples with incomplete pathological information, samples for which the information of positive cases cannot clarify the pathological results and tumor staging 6. Contaminated samples 7. Patients whose urine samples fail to pass the quality control due to reasonable reasons and cannot be sampled again 8. Samples that cannot be tested due to reasonable reasons 9. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements 10. Patients who cannot provide written informed consent
References
Publications (3)
- BACKGROUNDXu Y, Ma X, Ai X, Gao J, Liang Y, Zhang Q, Ma T, Mao K, Zheng Q, Wang S, Jiao Y, Zhang X, Li H. A Urine-Based Liquid Biopsy Method for Detection of Upper Tract Urinary Carcinoma. Front Oncol. 2021 Feb 9;10:597486. doi: 10.3389/fonc.2020.597486. eCollection 2020. PMID 33634022
- DERIVEDYi L, Ma Z, Zhang J, Zhan Y, Xiao H, Dai K, Liu Y, Gao Y, Yang X, Cao D, Xu D, Huang H. A stratified urine-based molecular diagnostic and prognostic model for non-muscle-invasive bladder cancer management. BMC Cancer. 2026 Jun 22. doi: 10.1186/s12885-026-16361-z. Online ahead of print. PMID 42332658
- DERIVEDHuang H, Liu A, Liang Y, Xin Y, Liu J, Hao Y, Huang D, Chen L, Li W, Jiang G, Huang Y, Xu Y, Zhang J, Ma T, Xu D, Gao Y. A urinary assay for mutation and methylation biomarkers in the diagnosis and recurrence prediction of non-muscle invasive bladder cancer patients. BMC Med. 2023 Sep 19;21(1):357. doi: 10.1186/s12916-023-03065-5. PMID 37726806