Liquid biopsy testing to identify, monitor, and predict recurrence in urothelial carcinoma
Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma
This project tests whether a multi-component liquid biopsy (blood and urine ctDNA, urine tumor DNA, exosomes, and protein biomarkers) can help detect disease, track treatment response, and predict recurrence in people with suspected or confirmed urothelial carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University Second Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07441499 on ClinicalTrials.gov |
What this trial studies
This observational study will collect serial blood and urine samples from people with suspected or confirmed urothelial carcinoma and analyze circulating tumor DNA (ctDNA), urine tumor DNA (utDNA), exosomes, and protein biomarkers. Researchers will compare these molecular signals with clinical findings, imaging, and pathology to determine their relationship to diagnosis, therapeutic response, and recurrence. The study emphasizes combining multiple biomarker types to improve sensitivity and specificity versus single-analyte tests. Resulting data may be used to develop predictive algorithms or signatures for recurrence risk and monitoring.
Who should consider this trial
Good fit: Ideal candidates are people with suspected or histologically confirmed urothelial carcinoma who can provide blood and urine samples and attend follow-up visits at the study site.
Not a fit: Patients with a history of or concurrent active non-urothelial malignancies, or those unable to provide serial samples or attend the Tianjin site, are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier and less invasive detection of recurrence and improved monitoring of treatment response, potentially reducing reliance on invasive procedures like cystoscopy.
How similar studies have performed: Prior ctDNA and urine-DNA studies in bladder cancer have shown promise for detection and monitoring, but combining ctDNA, utDNA, exosomes, and protein biomarkers is a relatively new approach that has not yet been widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected or histologically confirmed urothelial carcinoma Exclusion Criteria: * History of or concurrent active malignancy other than urothelial carcinoma
Where this trial is running
Tianjin
- The second hospital of Tianjin Medical University — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Hailong Hu, MD
- Email: huhailong@tmu.edu.cn
- Phone: +8613662096232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.