NCT07756437Recruiting
Validation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer
Internal Validation of Circulating Tumor DNA (ctDNA) Sequencing in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 7 Nov 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- AZ Sint-Lucas Gent
- Diseases
- Bladder cancer
- NCT number
- NCT07756437
What you commit to
- Study type: Observational
- Planned participants: 70
- From 7 Nov 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Concurrent active malignancy diagnosed within the past 5 years.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint-Lucas Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.