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

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.

Eligibility

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)

Conditions2

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