Non Muscle Invasive Bladder CancerNCT07036731
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
A study testing Urine biomarker -Guided without reTURBT in people with Non Muscle Invasive Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Urine biomarker -Guided without reTURBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
- Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.), posing a risk of residual tumor;
- Absence of muscle layer tissue in the initial resection specimen;
- Post-initial resection pathology indicating T1 stage;
- Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
- Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
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- Age ≥ 18 years;
- Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
- Willingness to sign the informed consent form.
Who cannot join
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second resection;
- Patients with incomplete pathological information of the sample;
- Patients with contaminated samples;
- Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
- Any condition deemed by the investigator as potentially harming the subject or preventing the subject from meeting or fulfilling the study requirements;
- Patients unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029
Nanjing, Jiangsu
Yang xiao, PhD, +8613951813528, yangxiao2915@163.com
About this study
Official title: A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Urine biomarker -Guided without reTURBT
- Keywords
- reTURBT; NMIBC; urine biomarker; RFS
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Fanconi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine biomarker -Guided without reTURBTProcedure or surgery
Participants will proceed without reTURBT
| Study group | Role | What they receive |
|---|---|---|
| Urine biomarker -Guided without reTURBT | Experimental | Participants in this arm will proceed without reTURBT if Urine biomarker tested negative Receives: Procedure: Urine biomarker -Guided without reTURBT |
| Standard Care with reTURBT | No intervention | Participants in this arm will receive standard care, which undergo reTURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year RFS rate
the proportion of participants experiencing a recurrence during follow-up within 2 years
Measured: from initial TURBT to the first confirmed recurrence within 2 years
Secondary outcomes (1)
RFS
the duration from the completion of initial TURBT until the first recurrence of cancer is detected or until the end of the follow-up period, whichever comes first.
Measured: from initial TURBT to the first confirmed recurrence within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Feb 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Lv, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036731
- Sponsor's protocol ID
- 2025-SR-310
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
- ClinicalTrials.gov ID
- NCT07036731
- Acronym / sponsor ID
- 2025-SR-310
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- reTURBT; NMIBC; urine biomarker; RFS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 25 Jun 2025 (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.
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Urine biomarker -Guided without reTURBT | Experimental | Procedure: Urine biomarker -Guided without reTURBTParticipants in this arm will proceed without reTURBT if Urine biomarker tested negative |
| Standard Care with reTURBT | No intervention | –Participants in this arm will receive standard care, which undergo reTURBT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:
- Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
- Age ≥ 18 years;
- Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
- Willingness to sign the informed consent form.
Key exclusion criteria (8 listed)
- Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
- Patients previously diagnosed with muscle-invasive bladder cancer;
- Patients unable to undergo a second resection;
- Patients with incomplete pathological information of the sample;
- Patients with 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 |
|---|---|---|
| Urine biomarker -Guided without reTURBTParticipants will proceed without reTURBT | Procedure or surgery | Urine biomarker -Guided without reTURBT |
Primary outcome
2-year RFS rate
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
the proportion of participants experiencing a recurrence during follow-up within 2 years
1 secondary outcome
RFS
Time frame: from initial TURBT to the first confirmed recurrence within 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine biomarker -Guided without reTURBT in people with Non Muscle Invasive 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 9 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang xiao, PhD (+8613951813528, yangxiao2915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year RFS rate (time frame: from initial TURBT to the first confirmed recurrence within 2 years). 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 25 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.