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
1 other identifier
observational
970
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJanuary 10, 2024
June 1, 2023
1.8 years
July 29, 2021
January 8, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Sensitivity
The sensitivity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
18 month
Specificity
The specificity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
18 month
Positive predictive value (PPV)
The positive predictive value (PPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
18 month
Negative predictive value (NPV)
The negative predictive value (NPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
18 month
Study Arms (4)
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
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
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
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
Interventions
Observational study only - no intervention
Eligibility Criteria
Patients with painless intermittent gross hematuria in outpatient/emergency/hospitalization; Patients diagnosed with non-muscular invasive urothelial carcinoma;
You may qualify if:
- 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:
- \) 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:
- \. 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 -
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Hangzhou Genetron Medical Laboratory Co., Ltd.collaborator
Study Sites (9)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Nanjing Zhongda Hospital
Nanjing, China
Luwan Branch of Shanghai Ruijin Hospital
Shanghai, China
Shanghai Fourth People's Hospital
Shanghai, China
Shanghai Ninth People's Hospital
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Wuxi People's Hospital
Wuxi, China
Xuzhou Central Hospital
Xuzhou, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Related Publications (2)
Xu 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: 33634022BACKGROUNDHuang 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: 37726806DERIVED
Related Links
Biospecimen
DNA extracted from urine sediment
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danfeng Xu
Ruijin Hospital
- STUDY DIRECTOR
Yiming Liang
Hangzhou Genetron Medical Laboratory Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 6, 2021
Study Start
April 1, 2022
Primary Completion
February 1, 2024
Study Completion
August 1, 2024
Last Updated
January 10, 2024
Record last verified: 2023-06