C67 C68
Conditions
Interventions
Group 1: Patients with metastatic urothelial carcinoma of the urinary bladder or upper urinary tract will be included to the study. After consenting to the study, patients will have a blood sample col
Sponsors
Hummingbird Diagnostics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Metastatic urothelial carcinoma of the urinary bladder or upper urinary tract (for primary diagnosis or recurrence). o Histological confirmation of invasive carcinoma of the urinary bladder or upper urinary tract or histological confirmation of a metastasis o Histological confirmation of urothelial carcinoma with at least 10% urothelial differentiation o Evidence of metastasis (lymph node or visceral) or local recurrence on imaging by computed tomography/MRI or histologic specimen. - Systemic chemotherapy or immunotherapy: o Adjuvant therapy for lymphogenic metastasis (evidence in surgical specimen). o Palliative first-line / second-line therapy o Maintenance therapy o Chemotherapy: cisplatin/gemcitabine; carboplatin/gemciatabine o Approved immunotherapy: pembrolizumab, atezolizumab, nivolumab, avelumab - ECOG 0 or 1 - Life expectancy greater than 3 months - Signed informed consent form - Age over 18 years
Exclusion criteria
Exclusion criteria: - Active known blood-borne viral diseases (AIDS, hepatitis B, hepatitis C). - Long-term immunosuppressive therapy o Glucocorticoids (daily dose > 10 mg prednisolone equivalent). o Other systemic immunosuppression (e.g. methotrexate) - Active autoimmune disease - Second malignancy receiving systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of overall survival (OS) between patients treated with immunotherapy or chemotherapy for metastatic urothelial carcinoma, subdivided by miRisk score (low vs. high). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Comparison of progression-free survival (PFS) between patients treated with immunotherapy or chemotherapy for metastatic urothelial carcinoma, subdivided by miRisk score (low vs. high) - Comparison of response rate (OR) to immunotherapy or chemotherapy subdivided by miRisk score (low vs. high) - Determination of the predictive and prognostic value of miRisk scores. | — |
Countries
Germany
Contacts
Public ContactFlorestan Koll
Universitätsklinikum Frankfurt, Klinik für Urologie
Outcome results
None listed