Detection of urothelial tumor risk genes using urine samples

A Study of the Urine Non-invasive Liquid Biopsy in Diagnosis and Recurrence Diagnosis of Urothelial Carcinoma

This study is testing a new urine test to see if it can better detect risk genes for bladder cancer compared to standard methods for patients who might have the disease.

Quick facts

• Study type: Observational
• Enrollment: 970 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Shanghai, Shanghai and 8 other locations)
• Trial ID: NCT04994197 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of the Genetron Uro V1 test, which detects mutations in 17 genes and methylation in 1 gene using urine and tumor tissue samples. The study compares the results of this urine liquid biopsy method with standard clinical diagnostic techniques for urothelial carcinoma. By analyzing the performance of Genetron Uro V1, the study seeks to enhance the accuracy of diagnosis and recurrence monitoring for patients with urothelial carcinoma. The study involves collecting urine samples from patients prior to cystoscopy and requires their consent for genetic testing.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 and older with hematuria or those diagnosed with non-muscular invasive urothelial carcinoma who are undergoing routine recurrence monitoring.

Not a fit: Patients who are under 18 years old or those who have not had their urothelial tumors surgically removed may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more accurate method for diagnosing and monitoring urothelial carcinoma.

How similar studies have performed: Other studies have shown promise in using liquid biopsy methods for cancer diagnosis, suggesting that this approach may yield beneficial results.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai and 8 other locations

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• Nanjing Zhongda Hospital — Nanjing, China (Recruiting)
• Luwan Branch of Shanghai Ruijin Hospital — Shanghai, China (Recruiting)
• Shanghai Fourth People's Hospital — Shanghai, China (Recruiting)
• Shanghai Ninth People's Hospital — Shanghai, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, China (Not_yet_recruiting)
• Wuxi People's Hospital — Wuxi, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, China (Not_yet_recruiting)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Danfeng Xu — Ruijin Hospital
• Study coordinator: Danfeng Xu

Conditions Urothelial Carcinoma