Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma

February 27, 2026 updated by: Tianjin Medical University Second Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China, 300000
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Suspected or histologically confirmed urothelial carcinoma

Exclusion Criteria:

  • History of or concurrent active malignancy other than urothelial carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Diagnostic test: Multi-Component Liquid Biopsy for Urothelial Carcinoma

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:

  1. Pre-diagnosis or baseline
  2. During treatment
  3. Post-treatment surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline (pre-treatment/diagnosis confirmation) or within the diagnostic window.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Truce-LBX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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