JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- iOMEDICO AG
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Course of treatment (treatment reality).
研究概览
简要总结
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.
详细描述
JADE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of HCC or CCC in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-related quality of life in patients with HCC / CCC will be evaluated for up to three years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage
- •Age ≥ 18 years
- •Signed and dated informed consent (IC):
- •For participation in the PRO module: Before primary locoregional therapy or start of first systemic treatment
- •For no participation in the PRO module: No later than 8 weeks after primary locoregional therapy or start of first systemic treatment
排除标准
- •Patients treated with best supportive care (BSC) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)
结局指标
主要结局
Course of treatment (treatment reality).
时间窗: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
次要结局
- Progression-free survival.(3 years per patient.)
- Best Response.(3 years per patient.)
- Overall survival.(3 years per patient.)
- Carcinoma Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)