Bladder CancerRE-TURBTNCT05112523
The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT
An observational study of Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results. To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 1 Aug 2023
- 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 receive a confirmed diagnosis of high-risk NMIBC at each study center and undergo the first TURBT
Who may be able to join
- Patients with a confirmed diagnosis of high-risk NMIBC at each study center:
- including (1) inadequate first TURBT; (2) absence of muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ alone; (3) stage T1 tumors; (4) grade G3 tumors, except for carcinoma in situ alone; (5) TaG1G2 meeting both multiple, recurrent, and >3 cm in diameter (or low-grade urothelial epithelial carcinoma)
- gender is not limited.
- age ≥ 18 years old.
- the ability to provide a 100 ml standing urine sample within 3-6 weeks after the first TURBT and before the secondary transurethral resection.
- agree to provide basic personal clinical information and pathological and imaging data for use in scientific research and sign an informed consent form related to scientific research.
- consent to perform the genetic testing services involved in the trial.
- agree to provide monitoring results in the follow-up relapse monitoring process.
Who cannot join
- patients with other non-uroepithelial malignancies (including prostate cancer and renal cell carcinoma).
- patients who failed to undergo secondary transurethral resection.
- patients with incomplete information on sample pathology.
- patients with contaminated samples.
- Patients whose urine samples fail quality control and cannot be re-sampled for valid reasons.
- Patients whose samples cannot complete the test due to reasonable cause.
- any condition that, in the opinion of the investigator, may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
- Patients who are unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Qiang Lu, PhD, 13505196501, dxhlvqiang@163.com
Xiao Yang, 13951813528, yangxiao2915@163.com
About this study
Official title: The Performance of Uroepithelial Cancer Risk Genes in the Necessity of Secondary Transurethral Resection of Bladder Tumor for High-risk Non-muscle-invasive Bladder Cancer: A Multicenter Clinical Trial
Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results. To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.
Read the detailed description
The standard of treatment for patients with non-muscle invasive bladder cancer (NMIBC) is transurethral resection of bladder tumors (TURBT), with postoperative intravesical irrigation treatment options determined by the risk of recurrence. After TURBT surgery, tumor remnants are one of the most important causes of postoperative tumor recurrence. Studies have shown that secondary TURBT can detect residual bladder tumor lesions, obtain more accurate pathological staging, increase recurrence-free survival, improve patient prognosis, and enhance treatment outcomes. Current bladder cancer treatment guidelines recommend secondary TURBT for patients with (1) inadequate first TURBT (2) no muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ (3) stage T1 tumors (4) grade G3 tumors, except for carcinoma in situ. However, at present, the lack of screening methods for the population benefiting from secondary TURBT in clinical practice has led to some patients inevitably receiving overtreatment, increasing patient suffering, and financial costs, and raising the burden of government healthcare.
The genetic test for uroepithelial tumor risk (Genetron Uro V1) is a non-invasive liquid biopsy method based on urine samples, which has high diagnostic efficacy in patients with primary uroepithelial cancer. Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results.
To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, TURBT, Liquid biopsy, Uroepithelial cancer risk genes
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology
Through Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of Genetron Uro V1 detected before secondary TURBT are measured.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Overall survival
To analyze the performance of the Genetron Uro V1 method in a study to predict the correlation with patient OS.
Measured: 2 years after surgery
Recurrence-free survival
To analyze the performance of the Genetron Uro V1 method in a study to predict the correlation with patient RFS.
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Dec 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Jichenjunchuang Medical Laboratory Company
- Responsible party
- Sponsor
- Investigators
- Qiang Lv, MD，PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112523
- Sponsor's protocol ID
- 2021-SR-277
- Acronym
- RE-TURBT
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Uroepithelial Cancer Risk Genes in the Necessity of Secondary Transurethral Resection of Bladder Tumor for High-risk Non-muscle-invasive Bladder Cancer: A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05112523
- Acronym / sponsor ID
- RE-TURBT / 2021-SR-277
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, TURBT, Liquid biopsy, Uroepithelial cancer risk genes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Jichenjunchuang Medical Laboratory Company
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Nov 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.
Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results. To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.
Detailed description
The standard of treatment for patients with non-muscle invasive bladder cancer (NMIBC) is transurethral resection of bladder tumors (TURBT), with postoperative intravesical irrigation treatment options determined by the risk of recurrence. After TURBT surgery, tumor remnants are one of the most important causes of postoperative tumor recurrence. Studies have shown that secondary TURBT can detect residual bladder tumor lesions, obtain more accurate pathological staging, increase recurrence-free survival, improve patient prognosis, and enhance treatment outcomes. Current bladder cancer treatment guidelines recommend secondary TURBT for patients with (1) inadequate first TURBT (2) no muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ (3) stage T1 tumors (4) grade G3 tumors, except for carcinoma in situ. However, at present, the lack of screening methods for the population benefiting from secondary TURBT in clinical practice has led to some patients inevitably receiving overtreatment, increasing patient suffering, and financial costs, and raising the burden of government healthcare.
The genetic test for uroepithelial tumor risk (Genetron Uro V1) is a non-invasive liquid biopsy method based on urine samples, which has high diagnostic efficacy in patients with primary uroepithelial cancer. Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results.
To analyze the performance of the Genetron Uro V1 method in a study to predict the need for secondary TURBT in high-risk NMIBC patients and the correlation with patient's RFS and OS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive a confirmed diagnosis of high-risk NMIBC at each study center and undergo the first TURBT
Key inclusion criteria (8 listed)
- Patients with a confirmed diagnosis of high-risk NMIBC at each study center:
- including (1) inadequate first TURBT; (2) absence of muscle tissue in the first TURBT specimen, except for TaG1 and carcinoma in situ alone; (3) stage T1 tumors; (4) grade G3 tumors, except for carcinoma in situ alone; (5) TaG1G2 meeting both multiple, recurrent, and >3 cm in diameter (or low-grade urothelial epithelial carcinoma)
- gender is not limited.
- age ≥ 18 years old.
- the ability to provide a 100 ml standing urine sample within 3-6 weeks after the first TURBT and before the secondary transurethral resection.
Key exclusion criteria (8 listed)
- patients with other non-uroepithelial malignancies (including prostate cancer and renal cell carcinoma).
- patients who failed to undergo secondary transurethral resection.
- patients with incomplete information on sample pathology.
- patients with contaminated samples.
- Patients whose urine samples fail quality control and cannot be re-sampled for valid reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology
Time frame: Through study completion, an average of 1 year
Through Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of Genetron Uro V1 detected before secondary TURBT are measured.
2 secondary outcomes
Overall survival
Time frame: 2 years after surgery
Recurrence-free survival
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Qiang Lv, MD，PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 8 inclusion and 8 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Lingkai Cai (+86 15206213500, lingkaicai1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance analysis of Genetron Uro V1 assay results with gold standard results of secondary TURBT histopathology (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2021.