Observational longitudinal trial of metastatic urothelial cancer patients to evaluate blood-based miRNA profiles (miRisk score) for treatment prognosis and efficacy prediction to immunotherapy

• Conditions: C67; C68; Malignant neoplasm of bladder; Malignant neoplasm of other and unspecified urinary organs

• Registration Number: DRKS00029942
• Lead Sponsor: Hummingbird Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of overall survival (OS) between patients treated with immunotherapy or chemotherapy for metastatic urothelial carcinoma, subdivided by miRisk score (low vs. high).

Secondary Outcome Measures

Name	Time	Method
- Comparison of progression-free survival (PFS) between patients treated with immunotherapy or chemotherapy for metastatic urothelial carcinoma, subdivided by miRisk score (low vs. high)<br>- Comparison of response rate (OR) to immunotherapy or chemotherapy subdivided by miRisk score (low vs. high)<br>- Determination of the predictive and prognostic value of miRisk scores.