Blood test for detecting tumor DNA in bladder and upper tract cancer
Official title: Internal Validation of Circulating Tumor DNA (ctDNA) Sequencing in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma: A Prospective Observational Study
Run by AZ Sint-Lucas Gent · NCT07756437 · Data updated 2026-11-12
A blood test that looks for tumor DNA in people with muscle-invasive bladder cancer or upper tract urothelial cancer is being tested to see if it matches what’s found in tumor tissue and if it can help track recurrence or remission over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | AZ Sint-Lucas Gent Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | June 1, 2029 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07756437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed muscle-invasive bladder cancer or suspected muscle-invasive upper tract urothelial carcinoma (stage T2 or higher) who have available tumor tissue for analysis and provide informed consent.
✕Probably not a fit
Patients whose tumors do not shed detectable ctDNA or who do not have a measurable mutation may not benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study conducted at AZ Sint-Lucas Gent to validate an internally developed ctDNA assay. Researchers compare tumor DNA mutations identified from tissue with mutations found in plasma DNA using a tumor-informed approach, mainly digital droplet PCR, with some sequencing as needed. The study also explores whether ctDNA presence or changes after treatment relate to patient outcomes over two years. No treatment is assigned by the study; participation involves blood draws and analysis during routine clinical care. The goal is to determine the assay’s accuracy and potential role in monitoring disease burden and response.
Why it matters
Potential benefit: If successful, the ctDNA test could provide a noninvasive method to monitor disease status and guide follow-up care.
How similar studies have gone: Previous studies in ctDNA and liquid biopsy have shown promise in other cancers, supporting further validation in urothelial cancers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Histologically confirmed muscle-invasive bladder cancer or suspected muscle-invasive upper tract urothelial carcinoma, stage T2 or higher. * Availability of tumor tissue from transurethral resection of bladder tumor, ureteroscopic biopsy, biopsy of a metastatic lesion, or nephroureterectomy for DNA extraction. * Written informed consent provided. Exclusion Criteria: \- Concurrent active malignancy diagnosed within the past 5 years.
Where it's running
-
AZ Sint-Lucas Gent
Ghent, East Flanders, Belgium Recruiting
Study contacts
- Study coordinator: Jeroen Van Besien, MD
- Email: Secretariaat.Urologie@AZSTLUCAS.BE
- Phone: 003292246650
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.