Urothelial CarcinomaNCT04994197
Urothelial Tumor Risk Genes Detection With Genetron Uro V1 and LC-WGS
An observational study of Urothelial Carcinoma, run by Ruijin Hospital at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 970 participants
- Where
- 9 sitesChina
- Study dates
- 1 Apr 2022to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with painless intermittent gross hematuria in outpatient/emergency/hospitalization; Patients diagnosed with non-muscular invasive urothelial carcinoma;
Who may be able to join
- 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:
Show all 11Show fewer
- 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 -
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Nanjing Zhongda Hospital
Nanjing
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Danfeng Xu, （021）64370045 ext. 666062, xdf12036@rjh.com.cn
Danfeng Xu
- Recruiting
Luwan Branch of Shanghai Ruijin Hospital
Shanghai
- Recruiting
Shanghai Fourth People's Hospital
Shanghai
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou
- Not yet recruiting
Wuxi People's Hospital
Wuxi
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou
- Not yet recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: A Study of the Urine Non-invasive Liquid Biopsy in Diagnosis and Recurrence Diagnosis of Urothelial Carcinoma
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.
Read the detailed description
The current diagnosis of urothelial carcinoma is mainly based on imaging examination, urine examination and endoscopy. Imaging examinations include ultrasound, CT, MRI, etc., which have limited clinical value when used alone, and are difficult to meet the demand for qualitative research on tumors. The current common methods are urine exfoliated cytology and fluorescence in situ hybridization (FISH). Urine exfoliative cytology is one of the main methods for diagnosis of urothelial cancer and follow-up after surgery. But the sensitivity of urine exfoliated cytology is about 13%-75%, and the specificity is 85%-100%. FISH can detect chromosomal abnormalities in urine exfoliated cells, and combined with urine exfoliated cytology can greatly improve the sensitivity of diagnosis, but the increased cost of multiple examination methods limits its use in diagnosis and each postoperative follow-up. Endoscopy includes cystoscopy and ureteroscopy. Cystoscopy is the most reliable way to diagnose bladder cancer, and some patients with upper urinary tract urothelial cancer also have bladder cancer. Therefore, cystoscopy is almost the "gold standard" method for the diagnosis of urothelial cancer. For most upper urinary tract urothelial cancers, ureteroscopic biopsy is the only method that can be used to pathological diagnosis before surgical resection. However, endoscopy is an invasive examination, which will cause additional pain and complications to the patient, and the resulting local adhesions or trauma will also increase the risk of postoperative recurrence. The characteristics of urothelial cancer are prone to recurrence. Therefore, there are strict follow-up time and standards after surgery. Endoscopy examination is required every three months or six months, which also increases the pain and expense of patients. Based on the above considerations, finding an accurate, non-destructive and economical urine biopsy diagnosis method is an urgent problem in the clinical research of urothelial cancer. Genetron Uro V1 has sensitivity, specificity, and NPV of the pre-diagnostic test for upper urinary tract urothelial carcinoma reached 92.2%, 91.9%, and 94.1%, respectively. Another urine biopsy method based on low-coverage whole-genome sequencing to detect copy number variation (CNV) in patients with urothelial tumors reported its application performance in the diagnosis of urothelial cancer, and its total sensitivity and specificity reached 80.4% and 94.9%, respectively. This project is to optimize new liquid biopsy methods (Genetron Uro V1 and LC-WGS)that will bring greater benefits to the clinic through more standard and larger clinical trials.
- Conditions
- Urothelial Carcinoma
- Being tested
- Observational study only - no intervention
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study only - no interventionOther
Observational study only - no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observational study only - no intervention | |
| 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 Receives: Other: Observational study only - no intervention | |
| 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 Receives: Other: Observational study only - no intervention | |
| 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 Receives: Other: Observational study only - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The sensitivity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Measured: 18 month
Specificity
The specificity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Measured: 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
Measured: 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
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Apr 2022
- Primary completionFeb 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 970 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Genetron Medical Laboratory Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Danfeng Xu, Principal investigator, Ruijin HospitalYiming Liang, Study director, Hangzhou Genetron Medical Laboratory Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994197
- Sponsor's protocol ID
- Genetron Uro V1-001
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33634022Yi 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.
PubMed 42332658Huang 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.
PubMed 37726806
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Urine Non-invasive Liquid Biopsy in Diagnosis and Recurrence Diagnosis of Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04994197
- Acronym / sponsor ID
- Genetron Uro V1-001
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 970 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Genetron Medical Laboratory Co., Ltd.
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current diagnosis of urothelial carcinoma is mainly based on imaging examination, urine examination and endoscopy. Imaging examinations include ultrasound, CT, MRI, etc., which have limited clinical value when used alone, and are difficult to meet the demand for qualitative research on tumors. The current common methods are urine exfoliated cytology and fluorescence in situ hybridization (FISH). Urine exfoliative cytology is one of the main methods for diagnosis of urothelial cancer and follow-up after surgery. But the sensitivity of urine exfoliated cytology is about 13%-75%, and the specificity is 85%-100%. FISH can detect chromosomal abnormalities in urine exfoliated cells, and combined with urine exfoliated cytology can greatly improve the sensitivity of diagnosis, but the increased cost of multiple examination methods limits its use in diagnosis and each postoperative follow-up. Endoscopy includes cystoscopy and ureteroscopy. Cystoscopy is the most reliable way to diagnose bladder cancer, and some patients with upper urinary tract urothelial cancer also have bladder cancer. Therefore, cystoscopy is almost the "gold standard" method for the diagnosis of urothelial cancer. For most upper urinary tract urothelial cancers, ureteroscopic biopsy is the only method that can be used to pathological diagnosis before surgical resection. However, endoscopy is an invasive examination, which will cause additional pain and complications to the patient, and the resulting local adhesions or trauma will also increase the risk of postoperative recurrence. The characteristics of urothelial cancer are prone to recurrence. Therefore, there are strict follow-up time and standards after surgery. Endoscopy examination is required every three months or six months, which also increases the pain and expense of patients. Based on the above considerations, finding an accurate, non-destructive and economical urine biopsy diagnosis method is an urgent problem in the clinical research of urothelial cancer. Genetron Uro V1 has sensitivity, specificity, and NPV of the pre-diagnostic test for upper urinary tract urothelial carcinoma reached 92.2%, 91.9%, and 94.1%, respectively. Another urine biopsy method based on low-coverage whole-genome sequencing to detect copy number variation (CNV) in patients with urothelial tumors reported its application performance in the diagnosis of urothelial cancer, and its total sensitivity and specificity reached 80.4% and 94.9%, respectively. This project is to optimize new liquid biopsy methods (Genetron Uro V1 and LC-WGS)that will bring greater benefits to the clinic through more standard and larger clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diagnosis group of patients with urothelial cancer | – | Other: Observational study only - no interventionPatients 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 | – | Other: Observational study only - no interventionPatients 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 | – | Other: Observational study only - no interventionPatients 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 | – | Other: Observational study only - no interventionPatients who were diagnosed with non-muscle invasive urothelial carcinoma and diagnosed as benign urinary diseases in this study will be assigned to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with painless intermittent gross hematuria in outpatient/emergency/hospitalization; Patients diagnosed with non-muscular invasive urothelial carcinoma;
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study only - no interventionObservational study only - no intervention | Other | Diagnosis group of patients with benign urinary diseases, Diagnosis group of patients with urothelial cancer, Recurrence diagnosis group with benign urinary diseases, Recurrence diagnosis group with urothelial cancer |
Primary outcome
Sensitivity
Time frame: 18 month
The sensitivity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Specificity
Time frame: 18 month
The specificity of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Positive predictive value (PPV)
Time frame: 18 month
The positive predictive value (PPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Negative predictive value (NPV)
Time frame: 18 month
The negative predictive value (NPV) of Genetron Uro V1 and LC-WGS in the auxiliary diagnosis and recurrence diagnosis of urothelial carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 33634022Xu 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.
- Derived from this study: PubMed 42332658Yi 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.
- Derived from this study: PubMed 37726806Huang 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.
- The diagnostic performance of Gentron Uro V1 in the upper urinary tract urothelial carcinomaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danfeng Xu principal investigator
Ruijin Hospital
Yiming Liang study director
Hangzhou Genetron Medical Laboratory Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Ruijin Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danfeng Xu (021-64370045 ext. 666062, xdf12036@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 18 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.