Clinical Research Platform For Molecular Testing, Treatment, Quality Of Life And Outcome Of Patients With Esophageal, Gastric Or Gastroesophageal Junction Cancer Requiring Palliative Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 1,900
- 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 esophageal, gastric or gastroesophageal junction cancer, treated in palliative intention in daily routine practice in Germany.
详细描述
SAPHIR is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic esophageal, gastric or gastroesophageal junction Cancer in Germany. The registry will follow patients for up to two 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 two 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
- •Histologically proven stage IV (metastatic) ESCC, EAC, GAC or GEJAC
- •Planned palliative systemic first-line therapy
- •Age >= 18 years
- •Signed informed consent (IC)
- •Patients answering questionnaires: IC before first therapy cycle
- •Patients not answering questionnaires: IC latest 4 weeks after start of first therapy cycle
排除标准
- •No systemic therapy for ESCC, EAC, GAC or GEJAC
研究组 & 干预措施
ESCC
250 patients with esophageal squamous cell carcinoma
干预措施: Routine care as per site standard (Other)
GAC
920 patients with gastric adenocarcinoma
干预措施: Routine care as per site standard (Other)
GEJAC
580 patients with gastroesophageal junction adenocarcinoma
干预措施: Routine care as per site standard (Other)
EAC
150 patients with esophageal adenocarcinoma
干预措施: Routine care as per site standard (Other)
结局指标
主要结局
Course of treatment (treatment reality)
时间窗: 2 years per patient
Documentation of anamnestic data and therapy sequences
次要结局
未报告次要终点