RecruitingNot Applicable

Validation of a Circulating Tumor DNA Blood Test in Muscle-Invasive Bladder and Upper Tract Urothelial Cancer

Belgium70 participantsStarted 2025-11-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic Performance of Plasma ctDNA for Detecting Tumor-Specific Mutations

Timeframe: From enrollment until completion of tumor tissue sequencing and matched plasma ctDNA analysis, up to 6 months

Trial details

NCT IDNCT07756437

SponsorAZ Sint-Lucas Gent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

Contact for this trial

Jeroen Van Besien, MD

003292246650 Secretariaat.Urologie@AZSTLUCAS.BE

View on ClinicalTrials.gov More Muscle-Invasive Bladder Cancer (MIBC) trials