Urothelial Carcinoma (UC)NCT07441499
Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
An observational study of Urothelial Carcinoma (UC) and Bladder (Urothelial, Transitional Cell) Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma (UC), Bladder (Urothelial, Transitional Cell) Cancer, Liquid Biopsy
- What is being tested?
- Multi-Component Liquid Biopsy for Urothelial Carcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to 1 Jan 2029
- 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: This observational cohort study enrolls adult patients (≥18 years) with suspected or histologically confirmed urothelial carcinoma (UC), including non-muscle-invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), metastatic urothelial carcinoma, and upper tract urothelial carcinoma (UTUC) of the renal pelvis or ureter. Participants are recruited from urology/oncology clinics at participating centers. The study population consists: Patients with clinical suspicion of UC and patients with pathologically confirmed UC at any stage.
Who may be able to join
- Suspected or histologically confirmed urothelial carcinoma
Who cannot join
- History of or concurrent active malignancy other than urothelial carcinoma
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 second hospital of Tianjin Medical University
Tianjin, 300000
Hailong Hu, +8613662096232, huhailong@tmu.edu.cn
About this study
Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma
- Being tested
- Multi-Component Liquid Biopsy for Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Component Liquid Biopsy for Urothelial CarcinomaDiagnostic test
This intervention is a non-invasive, multi-component liquid biopsy assay specifically designed for patients with urothelial carcinoma (including bladder cancer and upper tract urothelial carcinoma). It integrates multiple tumor-derived analytes from paired blood and urine samples: circulating cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) from peripheral blood plasma, urinary tumor DNA (utDNA)/cell-free DNA from urine, exosomal RNAs (e.g., miRNAs, lncRNAs) and proteins from urine-derived exosomes, and selected tumor-associated proteins.
Serial sampling is performed at key clinical time points to enable longitudinal assessment:
- Pre-diagnosis or baseline
- During treatment
- Post-treatment surveillance
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Diagnostic Test: Multi-Component Liquid Biopsy for Urothelial Carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Concordance
The proportion of patients in whom the molecular alterations (e.g., somatic mutations in key genes such as FGFR3, TP53, TERT promoter, PLEKHS1; methylation signatures; or multi-omic features) detected in multi-component liquid biopsy (blood ctDNA/cfDNA + urine utDNA/exosomal components) match those identified in the reference tissue biopsy or surgical specimen (gold standard).
Measured: At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.
Secondary outcomes (1)
Dynamic concordance during treatment/follow-up
The degree of agreement between longitudinal changes in multi-component liquid biopsy markers (primarily variant allele frequency [VAF] of key somatic mutations in ctDNA from blood and utDNA from urine, as well as exosomal RNA/protein levels where applicable) and clinical/radiological/pathological response endpoints
Measured: Serial assessments at baseline, during treatment (e.g., after each cycle or at predefined intervals such as 4-8 weeks), post-treatment (e.g., 3, 6, 12 months, and annually thereafter), up to 24-36 months or until progression/recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startMar 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma (UC)Studies 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
- 300 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
- NCT07441499
- Sponsor's protocol ID
- Truce-LBX
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The primary reason is to protect participant privacy and confidentiality, as the study involves sensitive clinical and molecular data (e.g., ctDNA/utDNA profiles, exosomal components) from patients with urothelial carcinoma. De-identification alone may not fully eliminate re-identification risks in this context, particularly given the rarity of certain genomic alterations and potential linkage to clinical records. Additionally, the informed consent and institutional ethics committee approval did not include provisions for broad secondary use or sharing of raw individual-level data beyond the study team. Results will be disseminated through peer-reviewed publications and aggregate summaries to maintain transparency while prioritizing participant protection.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07441499
- Acronym / sponsor ID
- Truce-LBX
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 2 Mar 2026 (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.
Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Multi-Component Liquid Biopsy for Urothelial Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational cohort study enrolls adult patients (≥18 years) with suspected or histologically confirmed urothelial carcinoma (UC), including non-muscle-invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), metastatic urothelial carcinoma, and upper tract urothelial carcinoma (UTUC) of the renal pelvis or ureter. Participants are recruited from urology/oncology clinics at participating centers. The study population consists: Patients with clinical suspicion of UC and patients with pathologically confirmed UC at any stage.
Key inclusion criteria (1 listed)
- Suspected or histologically confirmed urothelial carcinoma
Key exclusion criteria (1 listed)
- History of or concurrent active malignancy other than 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 |
|---|---|---|
| Multi-Component Liquid Biopsy for Urothelial CarcinomaThis intervention is a non-invasive, multi-component liquid biopsy assay specifically designed for patients with urothelial carcinoma (including bladder cancer and upper tract urothelial carcinoma). It integrates multiple tumor-derived analytes from paired blood and urine samples: circulating cell-free DNA (cfDNA)/circulating tumor DNA (ctDNA) from peripheral blood plasma, urinary tumor DNA (utDNA)/cell-free DNA from urine, exosomal RNAs (e.g., miRNAs, lncRNAs) and proteins from urine-derived exosomes, and selected tumor-associated proteins. Serial sampling is performed at key clinical time points to enable longitudinal assessment: 1. Pre-diagnosis or baseline 2. During treatment 3. Post-treatment surveillance | Diagnostic test | Study group |
Primary outcome
Diagnostic Concordance
Time frame: At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.
The proportion of patients in whom the molecular alterations (e.g., somatic mutations in key genes such as FGFR3, TP53, TERT promoter, PLEKHS1; methylation signatures; or multi-omic features) detected in multi-component liquid biopsy (blood ctDNA/cfDNA + urine utDNA/exosomal components) match those identified in the reference tissue biopsy or surgical specimen (gold standard).
1 secondary outcome
Dynamic concordance during treatment/follow-up
Time frame: Serial assessments at baseline, during treatment (e.g., after each cycle or at predefined intervals such as 4-8 weeks), post-treatment (e.g., 3, 6, 12 months, and annually thereafter), up to 24-36 months or until progression/recurrence
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 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The primary reason is to protect participant privacy and confidentiality, as the study involves sensitive clinical and molecular data (e.g., ctDNA/utDNA profiles, exosomal components) from patients with urothelial carcinoma. De-identification alone may not fully eliminate re-identification risks in this context, particularly given the rarity of certain genomic alterations and potential linkage to clinical records. Additionally, the informed consent and institutional ethics committee approval did not include provisions for broad secondary use or sharing of raw individual-level data beyond the study team. Results will be disseminated through peer-reviewed publications and aggregate summaries to maintain transparency while prioritizing participant protection.
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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?
An observational study of Urothelial Carcinoma (UC) and Bladder (Urothelial, Transitional Cell) Cancer, run by Tianjin Medical University Second Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 2 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 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 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?
Diagnostic Concordance (time frame: At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.). 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 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.