- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04994197
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Danfeng Xu
- Phone Number: 666062 021-64370045
- Email: xdf12036@rjh.com.cn
Study Locations
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Nanjing, China
- Recruiting
- Nanjing Zhongda Hospital
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Shanghai, China
- Recruiting
- Shanghai Ninth People's Hospital
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Shanghai, China
- Recruiting
- Luwan Branch of Shanghai Ruijin Hospital
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Shanghai, China
- Recruiting
- Shanghai Fourth People's Hospital
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Suzhou, China
- Not yet recruiting
- The First Affiliated Hospital of Soochow University
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Wuxi, China
- Not yet recruiting
- Wuxi People's Hospital
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Xuzhou, China
- Not yet recruiting
- Xuzhou Central Hospital
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Zhengzhou, China
- Not yet recruiting
- First Affiliated Hospital of Zhengzhou University
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
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Contact:
- Danfeng Xu
- Phone Number: 666062 (021)64370045
- Email: xdf12036@rjh.com.cn
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Principal Investigator:
- Danfeng Xu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients with painless intermittent gross hematuria in outpatient/emergency/hospitalization;
Patients diagnosed with non-muscular invasive urothelial carcinoma;
Description
Inclusion Criteria:
Diagnosis Group:
- Randomly enrolled hematuria patients in outpatient/emergency/inpatient care
- Gender is not limited
- Age ≥18 years old
- Able to provide 100ml urine sample before cystoscopy
- 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:
- 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
- Agree to conduct genetic testing services involved in the experiment -
Exclusion Criteria:
Diagnosis group:
- Patients with other non-urothelial malignancies (including prostate cancer and renal cell carcinoma)
- Patients with secondary urothelial tumors
- Patients who cannot undergo cystoscopy and urine exfoliative cytology
- Samples with incomplete pathological information, and samples with positive case information that cannot clarify the pathological results and tumor staging
- Contaminated samples
- Patients whose urine samples fail to pass the quality control due to reasonable reasons and cannot be sampled again
- Samples that cannot be tested due to reasonable reasons
- 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
- Patients who cannot provide written informed consent
Recurrence diagnosis group:
- Patients with other non-urothelial malignancies (including prostate cancer and renal cell carcinoma)
- Patients who cannot undergo cystoscopy and urine exfoliative cytology
- Patients planning to undergo cystectomy/neoadjuvant chemotherapy/radiotherapy
- Patients who have been enrolled at the pre-recurrence monitoring time point
- Samples with incomplete pathological information, samples for which the information of positive cases cannot clarify the pathological results and tumor staging
- Contaminated samples
- Patients whose urine samples fail to pass the quality control due to reasonable reasons and cannot be sampled again
- Samples that cannot be tested due to reasonable reasons
- 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
- Patients who cannot provide written informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diagnosis group of patients with urothelial cancer
Patients with painless intermittent gross hematuria during outpatient/emergency/hospitalization diagnose as urothelial carcinoma in this study will be assigned to this group
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Observational study only - no intervention
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Diagnosis group of patients with benign urinary diseases
Patients with painless intermittent gross hematuria during outpatient/emergency/hospitalization diagnose as benign urinary diseases in this study will be assigned to this group
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Observational study only - no intervention
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Recurrence diagnosis group with urothelial cancer
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
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Observational study only - no intervention
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Recurrence diagnosis group with benign urinary diseases
Patients who were diagnosed with non-muscle invasive urothelial carcinoma and diagnosed as benign urinary diseases in this study will be assigned to this group
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Observational study only - no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: 18 month
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The sensitivity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
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18 month
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Specificity
Time Frame: 18 month
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The specificity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
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18 month
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Positive predictive value (PPV)
Time Frame: 18 month
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The positive predictive value (PPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
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18 month
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Negative predictive value (NPV)
Time Frame: 18 month
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The negative predictive value (NPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
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18 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Danfeng Xu, Ruijin Hospital
- Study Director: Yiming Liang, Hangzhou Genetron Medical Laboratory Co., Ltd.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Genetron Uro V1-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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