Bladder CancerNCT07130578
The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer
An observational study of Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 2 sites in China.
Trial summary
High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Liquid Biopsy
- What is being tested?
- urine tumor DNA/RNA testing
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2025to 1 May 2027
- Phase
- Observational
- 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
Study population: Adults (≥18 years) with histologically confirmed high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone initial transurethral resection of bladder tumor (TURBT) and are scheduled for second TURBT. Eligible tumors are urothelial carcinoma or bladder tumors with urothelial carcinoma as the predominant component (>50%), with no evidence of muscle-invasive or metastatic disease.
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.
- Voluntarily agrees to participate in the study, has signed informed consent, demonstrates good compliance, and is willing to complete study follow-up.
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yunkai Qie, MD contact
China2 sites, 2 recruiting
- Recruiting
General Hospital of Tianjin Medical University
Tianjin, 300000
Liang Wang, +8619808926211, 906062437@qq.com
- Recruiting
The second hospital of Tianjin Medical University
Tianjin
Hailong Hu, MD, +8613662096232, hhllove2004@163.com
About this study
Official title: Truce-LB00:The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer: An Open-Label, Observational, Single-Center Clinical Study
High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and obtain additional pathological information. However, the actual survival benefit of routine re-TURBT for all high-risk patients remains debated, and the procedure may pose surgical risks, increase healthcare costs, and impact patient quality of life.
Urine tumor DNA (utDNA) and urine tumor RNA (utRNA) are molecular biomarkers detectable through non-invasive "liquid biopsy" methods. In urothelial carcinoma, tumor-derived nucleic acids can be shed into urine, where they can be detected with high sensitivity and specificity. These biomarkers may help identify patients most likely to harbor residual disease after initial TURBT, and thus most likely to benefit from re-TURBT.
This prospective, open-label, observational, single-center study aims to evaluate the clinical value of utDNA/utRNA testing in guiding re-TURBT for patients with high-risk NMIBC. The study will assess whether molecular urine testing can improve patient selection for re-TURBT, potentially reducing unnecessary procedures while maintaining oncological safety.
- Conditions
- Bladder Cancer, Liquid Biopsy
- Being tested
- urine tumor DNA/RNA testing
- Keywords
- Bladder Cancer, Liquid Biopsy, NMIBC, re-TURBT
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine tumor DNA/RNA testingDiagnostic test
The test analyzes DNA and RNA fragments shed by urothelial carcinoma cells into urine, detecting tumor-specific genetic and epigenetic alterations.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All enrolled patients will undergo urine tumor DNA (utDNA) and urine tumor RNA (utRNA) testing between 2-6 weeks after the initial transurethral resection of bladder tumor (TURBT) and prior to the second TURBT (re-TURBT). The re-TURBT procedure will include deep resection at the site of the original tumor base, complete resection of tumor margins and any suspicious areas, as well as random bladder biopsies as indicated. The results of utDNA/utRNA testing will be compared with pathological findings from the re-TURBT specimens to evaluate the diagnostic value of molecular urine testing in detecting residual disease. Receives: Diagnostic Test: urine tumor DNA/RNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance analysis of urine tumor DNA/RNA testing results with results of secondary TURBT histopathology
Through Concordance analysis of urine tumor DNA/RNA testing results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) are measured.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT07130578
- Sponsor's protocol ID
- Truce-LB00
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Truce-LB00:The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer: An Open-Label, Observational, Single-Center Clinical Study
- ClinicalTrials.gov ID
- NCT07130578
- Acronym / sponsor ID
- Truce-LB00
- Conditions
- Bladder Cancer, Liquid Biopsy
- Keywords
- Bladder Cancer, Liquid Biopsy, NMIBC, re-TURBT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Aug 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.
High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT). Current guidelines recommend a second TURBT (re-TURBT) within 2-6 weeks for patients with stage T1 disease to remove residual tumor, confirm staging, and obtain additional pathological information. However, the actual survival benefit of routine re-TURBT for all high-risk patients remains debated, and the procedure may pose surgical risks, increase healthcare costs, and impact patient quality of life.
Urine tumor DNA (utDNA) and urine tumor RNA (utRNA) are molecular biomarkers detectable through non-invasive "liquid biopsy" methods. In urothelial carcinoma, tumor-derived nucleic acids can be shed into urine, where they can be detected with high sensitivity and specificity. These biomarkers may help identify patients most likely to harbor residual disease after initial TURBT, and thus most likely to benefit from re-TURBT.
This prospective, open-label, observational, single-center study aims to evaluate the clinical value of utDNA/utRNA testing in guiding re-TURBT for patients with high-risk NMIBC. The study will assess whether molecular urine testing can improve patient selection for re-TURBT, potentially reducing unnecessary procedures while maintaining oncological safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: urine tumor DNA/RNA testingAll enrolled patients will undergo urine tumor DNA (utDNA) and urine tumor RNA (utRNA) testing between 2-6 weeks after the initial transurethral resection of bladder tumor (TURBT) and prior to the second TURBT (re-TURBT). The re-TURBT procedure will include deep resection at the site of the original tumor base, complete resection of tumor margins and any suspicious areas, as well as random bladder biopsies as indicated. The results of utDNA/utRNA testing will be compared with pathological findings from the re-TURBT specimens to evaluate the diagnostic value of molecular urine testing in detecting residual disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with histologically confirmed high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone initial transurethral resection of bladder tumor (TURBT) and are scheduled for second TURBT. Eligible tumors are urothelial carcinoma or bladder tumors with urothelial carcinoma as the predominant component (>50%), with no evidence of muscle-invasive or metastatic disease.
Key inclusion criteria (12 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 |
|---|---|---|
| urine tumor DNA/RNA testingThe test analyzes DNA and RNA fragments shed by urothelial carcinoma cells into urine, detecting tumor-specific genetic and epigenetic alterations. | Diagnostic test | Study group |
Primary outcome
Concordance analysis of urine tumor DNA/RNA testing results with results of secondary TURBT histopathology
Time frame: Through study completion, an average of 6 months
Through Concordance analysis of urine tumor DNA/RNA testing results with gold standard results of secondary TURBT histopathology, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) are measured.
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Yunkai Qie, MD contact
2 sites 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 and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 2 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 12 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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, hhllove2004@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 urine tumor DNA/RNA testing results with results of secondary TURBT histopathology (time frame: Through study completion, an average of 6 months). 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 3 Mar 2026.