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临床试验/NCT04576858
NCT04576858招募中不适用

Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 1,950 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,950
试验地点
1
主要终点
Time to recurrence

研究概览

简要总结

This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

  • Surgical resection + perioperative chemotherapy (cohort 1)
  • Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)
  • Definitive chemoradiotherapy with curative intent (cohort 3)
  • Systemic therapy with the intent to prolong survival (cohort 4)
  • Palliative treatment without the use of chemotherapy (cohort 5)

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

入选标准

  • Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

排除标准

  • Patients not providing informed consent

结局指标

主要结局

Time to recurrence

时间窗: 1 year

次要结局

  • Time to progression(1 year)
  • Overall survival(5 year)
  • Response rate RECIST 1.1(through study completion, an average of 1 year)
  • Response duration RECIST 1.1(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Morten Mau-Sørensen

Chief Physician, MD, PhD

Rigshospitalet, Denmark

研究点 (1)

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