T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07581496

Enrollment

Registered

2026-05-12

Start date

2025-06-18

Completion date

2030-06-01

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief summary

T1G3 bladder cancer is a heterogeneous disease with a high risk of disease persistence after the first TUR-B, understaging, disease progression, bladder removal, and mortality. Current risk stratification is insufficient and needs improvement. Ct-DNA could identify patients with disease persistence, progression and could monitor and tailor therapy. It might improve patient risk stratification, avoiding under- and overtreatment, reducing morbidity and mortality. Primary objective is to investigate the detectability of ct-DNA in T1G3 urothelial bladder cancer patients and build a biobank through collection of different sample types (urine, plasma) in T1G3 bladder cancer patients which allows future retrospective testing.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Detectability of ct-DNA in T1G3 urothelial bladder cancer patients	From start of treatment 36 Months	Primary endpoint is the detectability of ct-DNA in T1G3 urothelial bladder cancer patients, whether there are dynamic changes during the different treatment steps (after TUR-BT, after re-TUR-BT, during instillation therapy) and if ct-DNA is predictive / prognostic in T1G3 urothelial bladder cancer patients.

Countries

Switzerland

Contacts

CONTACTHeike Püschel

Heike.Pueschel@usb.ch+41 61 55 65477

CONTACTNiklas Simon

niklas.simon@usb.ch+41 61 55 65616

PRINCIPAL_INVESTIGATORCyrill Rentsch, Prof.

Universitätsspital Basel

Outcome results