T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Detectability of ct-DNA in T1G3 urothelial bladder cancer patients [Time frame: From start of treatment 36 Months]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 2 centers
- Universitätsspital Basel — Basel
- Luzerner Kantonsspital — Lucerne
Identifiers
NCT: NCT07581496 · T1G3R-1