Recruiting

NCT Number: NCT07441499

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

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

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Key information

Conditions

Urothelial Carcinoma (UC) Bladder (Urothelial, Transitional Cell) Cancer Carcinoma Carcinoma, Transitional Cell Liquid Biopsy Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The second hospital of Tianjin Medical University

Tianjin, 300000, China

Location status: Recruiting

Location contact

Hailong Hu

CONTACT

[email protected]

+8613662096232

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Suspected or histologically confirmed urothelial carcinoma

Exclusion criteria

History of or concurrent active malignancy other than urothelial carcinoma

Treatment and study plan

Multi-Component Liquid Biopsy for Urothelial Carcinoma

Diagnostic 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

Primary outcomes

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).

Secondary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hailong Hu, MD

CONTACT

[email protected]

+8613662096232

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Second Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2029
First posted: Mar 2, 2026
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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