T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients with a proven T1G3 Bladder Cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Detectability of ct-DNA in T1G3 urothelial bladder cancer patients
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.
Time frame
From start of treatment 36 MonthsSponsors and contacts
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Source ClinicalTrials.gov