Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)
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
- 500
- 试验地点
- 1
- 主要终点
- Course of treatment (treatment reality).
研究概览
简要总结
The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.
详细描述
AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer 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 (HRQoL) will be evaluated for up to three years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with histologically proven metastatic colorectal cancer (stage IV) at time of inclusion (patients with metastatic disease and potential curative treatment intention are allowed)
- •Age ≥ 18 years
- •Planned first systemic therapy for metastatic disease
- •Signed and dated informed consent form
- •Patients participating in the PRO module: prior to or at start of first systemic treatment for mCRC
- •Patients not participating in the PRO module: within four weeks after start of fist systemic therapy for mCRC
排除标准
- •Patient who do not receive any systemic therapy for mCRC
- •Patients whose metastatic disease was surgically resected prior to inclusion and who start adjuvant chemotherapy
研究组 & 干预措施
Colorectal Cancer Metastatic
干预措施: Physician's choice according to patient's needs. (Other)
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.)
- Overall survival.(3 years per patient.)
- Carcinoma Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)
- Best Response.(3 years per patient.)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)