Detecting ctDNA to predict outcomes in high-grade T1 bladder cancer
Official title: T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
Run by University Hospital, Basel, Switzerland · NCT07581496 · Data updated 2026-11-12
This project will test whether tiny fragments of tumor DNA in urine or blood can be detected and used to predict outcomes for adults with high-grade T1 (T1G3) bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Basel and 1 other locations) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | June 1, 2030 |
| Study ends | June 1, 2030 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07581496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with cystoscopically proven bladder cancer suspected to be high-grade T1 (T1G3), able to give informed consent and scheduled for TUR-B at the participating Swiss centers are ideal candidates.
✕Probably not a fit
Patients with metastatic disease, concomitant upper-tract tumors, confirmed non-T1G3 pathology, or those who are upstaged at re-TUR-B or immediate cystectomy are unlikely to benefit from this project's ctDNA sampling.
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, non-interventional project enrolling adults with cystoscopically suspected T1G3 bladder cancer who will undergo TUR-B. Investigators will collect urine and plasma samples around standard care procedures to build a biobank for current and future ctDNA testing. The main goals are to determine how often ctDNA can be detected in these patients and whether ctDNA presence or levels relate to disease persistence or progression. No experimental treatments are given and clinical management follows routine care; patients with metastatic disease, concomitant upper-tract tumors, or confirmed non-T1G3 cancers are excluded from further sampling.
Why it matters
Potential benefit: If successful, ctDNA testing could help identify patients at higher risk who may need earlier or stronger treatment and spare low-risk patients from unnecessary procedures.
How similar studies have gone: Prior research in bladder and other cancers has shown ctDNA can be a promising biomarker for monitoring and prognosis, but its specific use in T1G3 bladder cancer is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients \> 18 years of age, able to give informed consent as documented by signature, * patients with a cystoscopically proven bladder cancer, suspicious for T1 stage, who will undergo TUR-B Exclusion Criteria: * Patients with metastases or concomitant upper tract tumor at diagnosis will * Patients with non T1 G3 cancers * Patients with upstaging, either at re-TUR-B or after immediate radical cystectomy * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * Vulnerable persons (e.g. \< 18y of age, unable to consent to the study)
Where it's running
-
Universitätsspital Basel
Basel, Switzerland Recruiting -
Luzerner Kantonsspital
Lucerne, Switzerland Recruiting
Study contacts
- Principal investigator: Cyrill Rentsch, Prof. — Universitätsspital Basel
- Study coordinator: Heike Püschel
- Email: Heike.Pueschel@usb.ch
- Phone: +41 61 55 65477
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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.