Checking a blood test for tumor DNA in bladder and upper urinary tract cancer
Checks how well a blood test finds tumor DNA in people with bladder cancer.
Plain-language title generated from the registry record
Registry title: Validation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer
Key facts
- Where
- Ghent, BelgiumSee the site
Where in Belgium
- AZ Sint-Lucas GentGhent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AZ Sint-Lucas Gent
- Trial code
- NCT07756437
- Record updated
- 10 August 2026
- Original description
This prospective observational study evaluates a blood-based circulating tumor DNA (ctDNA) test in patients with muscle-invasive bladder cancer or upper tract urothelial cancer. ctDNA consists of small fragments of tumor DNA that can sometimes be detected in the blood.Read full original descriptionShow less
Internal Validation of Circulating Tumor DNA (ctDNA) Sequencing in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma: A Prospective Observational Study
This prospective observational study evaluates a blood-based circulating tumor DNA (ctDNA) test in patients with muscle-invasive bladder cancer or upper tract urothelial cancer. ctDNA consists of small fragments of tumor DNA that can sometimes be detected in the blood.
In this study, DNA from tumor tissue obtained during routine diagnostic or surgical procedures will be analyzed to identify tumor-specific mutations. Blood samples collected during routine clinical care will then be tested to determine whether the same mutations can be detected in plasma ctDNA.
The main purpose is to assess how well the internally developed ctDNA assay detects tumor-specific mutations compared with tumor tissue sequencing. The study will also explore whether ctDNA results after treatment are associated with recurrence or remission during two years of follow-up, and whether changes in ctDNA levels during treatment are associated with pathological response.
This study does not assign participants to a treatment and does not require additional blood draws beyond routine care. Treating physicians will remain blinded to ctDNA results during the study, so the test results will not influence clinical decisions.
Inclusion: 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: Concurrent active malignancy diagnosed within the past 5 years.