Bladder CancerNCT07187635
Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer
A study testing Second Transurethral Resection of Bladder Tumor (re-TURBT) and utDNA Testing (Urine Tumor DNA Detection) in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 7 sites in China.
Trial summary
Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Liquid Biopsy, Repeat Transurethral Resection of Bladder Tumor
- What is being tested?
- Second Transurethral Resection of Bladder Tumor (re-TURBT) and utDNA Testing (Urine Tumor DNA Detection)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 7 sitesChina
- Study dates
- 28 Sep 2025to 1 Nov 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for the study:
- Male or female, aged 18 years or older.
- Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.
- Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (>50%).
- At least one of the following conditions:
- Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.
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- Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ [CIS]).
- T1 stage tumor.
- Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.
- Willingness to provide tumor tissue samples for pathological examination.
- Willingness to undergo genetic testing required for the trial.
Who cannot join
- Contraindications to transurethral resection of bladder tumor (TURBT).
- Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Xu Chen, +8619801210063, chenx457@mail.sysu.edu.cn
- Recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Haifeng Wang, +8613902821191, hfwurology@163.com
- Recruiting
Nanchang Second People's Hospital
Nanchang, Anhui
Tao Zeng, +8618722901012, zturology@163.com
- Recruiting
Renji Hospital
Shanghai
Ruiyun Zhang, MD, +8602158752345, zhangruiyun4337@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, MD, +8613662096232, huhailong@tmu.edu.cn
- Recruiting
General Hospital of Tianjin Medical University
Tianjin
Liang Wang, MD, +8619878120647, 906062437@qq.com
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei
Junli Wei, +8613702917784, wjlmnwk@163.com
About this study
Official title: The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)
Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs.
Urine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk.
This multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.
- Being tested
- Second Transurethral Resection of Bladder Tumor (re-TURBT), utDNA Testing (Urine Tumor DNA Detection)
- Keywords
- bladder cancer, liquid biopsy, second transurethral resection of bladder tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second Transurethral Resection of Bladder Tumor (re-TURBT)Procedure or surgery
Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, in accordance with current clinical guidelines.
utDNA Testing (Urine Tumor DNA Detection)Diagnostic test
Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing.
If utDNA is positive, the patient will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery.
If utDNA is negative, re-TURBT will be omitted and patients will proceed to guideline-based adjuvant therapy or surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Standard re-TURBT | Active comparator | Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, per guideline-based management. Receives: Procedure: Second Transurethral Resection of Bladder Tumor (re-TURBT) |
| utDNA-guided management | Experimental | Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing.
If utDNA positive, they will undergo re-TURBT within 2-6 weeks after the initial surgery.
If utDNA negative, re-TURBT will be omitted and patients will continue guideline-based adjuvant therapy/surveillance as per protocol. Receives: Diagnostic Test: utDNA Testing (Urine Tumor DNA Detection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Time from randomization to the first documented event of bladder tumor recurrence (any grade), upper tract urothelial recurrence.
Measured: Up to 24 months from randomization
Secondary outcomes (3)
Progression-free survival (PFS)
Time from initial TURBT to disease progression (development of muscle-invasive bladder cancer, distant metastasis).
Measured: Up to 24 months from randomization
Pathological outcomes of second transurethral resection (re-TURBT)
Proportion of patients with residual tumor, upstaging (higher T category at re-TURBT), or concomitant CIS among those undergoing repeat TURBT.
Measured: Perioperative (day of repeat TURBT)
Patient-reported outcomes
Health outcomes directly reported by the patient without interpretation by clinicians or others. These measures capture patients' perceptions of symptoms, functional status, health-related quality of life (HRQoL), and treatment-related burden.
Measured: Up to 24 months from randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start28 Sep 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187635
- Sponsor's protocol ID
- Truce-LB01
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)
- ClinicalTrials.gov ID
- NCT07187635
- Acronym / sponsor ID
- Truce-LB01
- Keywords
- bladder cancer, liquid biopsy, second transurethral resection of bladder tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Sep 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.
Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs.
Urine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk.
This multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard re-TURBT | Active comparator | Procedure: Second Transurethral Resection of Bladder Tumor (re-TURBT)Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, per guideline-based management. |
| utDNA-guided management | Experimental | Diagnostic Test: utDNA Testing (Urine Tumor DNA Detection)Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA positive, they will undergo re-TURBT within 2-6 weeks after the initial surgery. If utDNA negative, re-TURBT will be omitted and patients will continue guideline-based adjuvant therapy/surveillance as per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, aged 18 years or older.
- Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.
- Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (>50%).
- At least one of the following conditions:
- Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.
Key exclusion criteria (2 listed)
- Contraindications to transurethral resection of bladder tumor (TURBT).
- Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).
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 |
|---|---|---|
| Second Transurethral Resection of Bladder Tumor (re-TURBT)Participants with NMIBC who have undergone initial TURBT will not receive utDNA testing and will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery, in accordance with current clinical guidelines. | Procedure or surgery | Standard re-TURBT |
| utDNA Testing (Urine Tumor DNA Detection)Participants with NMIBC who have undergone initial TURBT will receive urine tumor DNA (utDNA) testing. If utDNA is positive, the patient will undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery. If utDNA is negative, re-TURBT will be omitted and patients will proceed to guideline-based adjuvant therapy or surveillance. | Diagnostic test | utDNA-guided management |
Primary outcome
Recurrence-free survival (RFS)
Time frame: Up to 24 months from randomization
Time from randomization to the first documented event of bladder tumor recurrence (any grade), upper tract urothelial recurrence.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 24 months from randomization
Pathological outcomes of second transurethral resection (re-TURBT)
Time frame: Perioperative (day of repeat TURBT)
Patient-reported outcomes
Time frame: Up to 24 months from randomization.
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 14 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second Transurethral Resection of Bladder Tumor (re-TURBT) and utDNA Testing (Urine Tumor DNA Detection) in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 7 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 2 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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 Hailong Hu, MD (+8613662096232, huhailong@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: Up to 24 months from randomization). 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 14 Aug 2026.