Bladder CancerNCT07180212
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer
A study testing utDNA testing + Urine Cytology and Cystoscopy + Urine Cytology in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 8 sites in China.
Trial summary
Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Liquid Biopsy, Cystoscopy
- What is being tested?
- utDNA testing + Urine Cytology and Cystoscopy + Urine Cytology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 8 sitesChina
- Study dates
- 20 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
- Male or female participants aged 18 years or older.
- Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.
- Prior to enrollment, participants must have undergone either:
- A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.
Who cannot join
- 1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University
Guangzhou
The First Affiliated Hospital of Harbin Medical University
Haerbin
The Second Affiliated Hospital of Kunming Medical University
Kunming
Nanchang Second People's Hospital
Nanchang
The second hospital of Tianjin Medical University
Tianjin, 300000
General Hospital of Tianjin Medical University
Tianjin
Tianjin Hospital
Tianjin
Xingtai People's Hospital
Xingtai, Hebei
About this study
Official title: The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)
Non-muscle-invasive bladder cancer (NMIBC) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology.
Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients.
Read more
This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods.
By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.
- Conditions
- Bladder Cancer, Liquid Biopsy, Cystoscopy
- Being tested
- utDNA testing + Urine Cytology, Cystoscopy + Urine Cytology
- Keywords
- bladder cancer, liquid biopsy, cystoscopy, urine tumor DNA
- 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.
utDNA testing + Urine CytologyDiagnostic test
Participants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.
Cystoscopy + Urine CytologyDiagnostic test
Participants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. Receives: Diagnostic Test: utDNA testing + Urine Cytology |
| Arm B | Active comparator | Participants will undergo cystoscopy and urine cytology every 3 months. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. Receives: Diagnostic Test: Cystoscopy + Urine Cytology |
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 histologically confirmed intravesical tumor recurrence (any grade/stage).
Measured: Up to 24 months from randomization.
Mean Number of Cystoscopic Examinations per Patient Within 2 Years
The mean number of cystoscopic examinations per patient within 2 years was calculated for both the intervention group and the control group. This measure represents the average total number of cystoscopy procedures undergone by each participant during the 24-month follow-up period.
Measured: Up to 24 months from randomization.
Secondary outcomes (7)
Progression-Free Survival (PFS)
Time from randomization to pathologic progression to muscle-invasive bladder cancer (≥T2), any newly diagnosed upper tract urothelial carcinoma (UTUC), distant metastasis from urothelial carcinoma, radical cystectomy or nephroureterectomy performed for oncologic progression, or urothelial carcinoma-specific death, whichever occurs first.
Measured: Up to 24 months from randomization.
Sensitivity of serial utDNA testing for detection of intravesical recurrence
Sensitivity is defined as the proportion of surveillance visits with histologically confirmed recurrence in which utDNA testing performed at the same visit is positive.
Measured: From randomization to 24 months.
Specificity of serial utDNA testing for detection of intravesical recurrence
Specificity is defined as the proportion of surveillance visits without recurrence in which utDNA testing is negative.
Measured: From randomization to 24 months.
Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence
Proportion of utDNA-positive surveillance visits with confirmed recurrence.
Measured: From randomization to 24 months.
Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence
Proportion of utDNA-negative surveillance visits without recurrence.
Measured: From randomization to 24 months.
Patient-reported health-related quality of life measured by EQ-5D-5L
Health-related quality of life (HRQoL) directly reported by patients without clinician interpretation, measured using the EQ-5D-5L questionnaire.
Measured: Up to 24 months from randomization.
Patient-reported health-related quality of life measured by EORTC QLQ-C30
Health-related quality of life directly reported by patients without clinician interpretation, assessed using the EORTC QLQ-C30 questionnaire.
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 posted18 Sep 2025
- Study start20 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 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
- NCT07180212
- Sponsor's protocol ID
- Truce-LB02
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 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 Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)
- ClinicalTrials.gov ID
- NCT07180212
- Acronym / sponsor ID
- Truce-LB02
- Conditions
- Bladder Cancer, Liquid Biopsy, Cystoscopy
- Keywords
- bladder cancer, liquid biopsy, cystoscopy, urine tumor DNA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 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) is usually treated with surgery to remove the tumor (transurethral resection of bladder tumor, or TURBT), often followed by bladder-instilled medications to reduce the chance of the cancer coming back. Even with this treatment, high-grade NMIBC can return or progress, so patients need regular check-ups, usually with cystoscopy (a camera examination of the bladder) and urine cytology.
Cystoscopy is effective but invasive, can cause discomfort, and carries risks such as infection and bleeding. This makes follow-up costly and sometimes burdensome for patients.
This study is testing whether a urine tumor DNA (utDNA) test - a type of "liquid biopsy" that detects cancer-related DNA changes in urine - can help guide the timing of cystoscopy for people with high-risk or very high-risk NMIBC. utDNA testing is non-invasive and has shown high accuracy in detecting bladder cancer, sometimes spotting signs of recurrence earlier than standard methods.
By combining utDNA testing with cystoscopy, we hope to safely reduce the number of unnecessary cystoscopies without missing cancer recurrences. The study will evaluate whether this approach can make bladder cancer follow-up more comfortable, more precise, and more efficient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Diagnostic Test: utDNA testing + Urine CytologyParticipants will undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. |
| Arm B | Active comparator | Diagnostic Test: Cystoscopy + Urine CytologyParticipants will undergo cystoscopy and urine cytology every 3 months. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 years or older.
- Histologically confirmed high-risk or very high-risk non-muscle-invasive urothelial carcinoma (NMIBC) of the bladder, as defined by the EAU 2025 NMIBC guidelines, or bladder tumors in which high-risk/very high-risk NMIBC constitutes more than 50% of the pathological composition, diagnosed within the past 2 years, with no evidence of muscle-invasive bladder cancer or metastatic disease.
- Prior to enrollment, participants must have undergone either:
- A.Second transurethral resection of bladder tumor (re-TURBT), or B.Complete initial TURBT with negative basal margins, peripheral margins, and multiple site biopsies, with pathological specimens including detrusor muscle and showing no residual tumor, and negative urine cytology at 2 weeks post-surgery.
Key exclusion criteria (1 listed)
- 1.History of upper urinary tract malignancy (ureter or renal pelvis) within the past 5 years or concurrent diagnosis of upper urinary tract urothelial carcinoma.
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 |
|---|---|---|
| utDNA testing + Urine CytologyParticipants undergo urine tumor DNA (utDNA) testing and urine cytology every 3 months, and cystoscopy once per year. If either utDNA or urine cytology is positive, an additional cystoscopy will be performed. If urine cytology is positive but cystoscopy is negative, or if two consecutive utDNA tests are positive while cystoscopy remains negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. | Diagnostic test | Arm A |
| Cystoscopy + Urine CytologyParticipants undergo cystoscopy and urine cytology every 3 months as per standard high-risk NMIBC surveillance. If urine cytology is positive but cystoscopy is negative, participants will undergo computed tomography urography (CTU) to evaluate the upper urinary tract. | Diagnostic test | Arm B |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Up to 24 months from randomization.
Time from randomization to the first histologically confirmed intravesical tumor recurrence (any grade/stage).
Mean Number of Cystoscopic Examinations per Patient Within 2 Years
Time frame: Up to 24 months from randomization.
The mean number of cystoscopic examinations per patient within 2 years was calculated for both the intervention group and the control group. This measure represents the average total number of cystoscopy procedures undergone by each participant during the 24-month follow-up period.
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months from randomization.
Sensitivity of serial utDNA testing for detection of intravesical recurrence
Time frame: From randomization to 24 months.
Specificity of serial utDNA testing for detection of intravesical recurrence
Time frame: From randomization to 24 months.
Positive Predictive Value (PPV) of serial utDNA testing for detection of intravesical recurrence
Time frame: From randomization to 24 months.
Negative Predictive Value (NPV) of serial utDNA testing for detection of intravesical recurrence
Time frame: From randomization to 24 months.
Patient-reported health-related quality of life measured by EQ-5D-5L
Time frame: Up to 24 months from randomization.
Patient-reported health-related quality of life measured by EORTC QLQ-C30
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 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional restrictions.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing utDNA testing + Urine Cytology and Cystoscopy + Urine Cytology in people with Bladder Cancer and Liquid Biopsy, run by Tianjin Medical University Second Hospital at 8 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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.). The study lists 2 primary outcomes in all. 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 28 Sep 2026.