RecruitingNCT07581496

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

35 participants

Start Date

Jun 18, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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)

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Locations(2)

Universitätsspital Basel

Basel, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

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NCT07581496


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