DRKS00029942尚未招募不适用
Observational longitudinal trial of metastatic urothelial cancer patients to evaluate blood-based miRNA profiles (miRisk score) for treatment prognosis and efficacy prediction to immunotherapy - UmiR-Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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