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临床试验/NCT01621919
NCT01621919Unknown不适用

Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1

研究概览

简要总结

S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.

详细描述

  1. S-1 metabolites concentration in plasma

  2. factors affecting plasma concentration

  • surgery subtype
  • serum creatinine
  1. systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration
  • enteritis
  • fatigue
  1. S-1 metabolites concentration in tears

  2. correlation of tear concentration with plasma concentration

  3. lacrimal drainage obstruction caused by S-1 administration, and its correlation with tear S-1 metabolites concentration

  4. lacrimal drainage obstruction caused by S-1 administration, and its correlation with plasma S-1 metabolites concentration

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received radical surgery for gastric cancer
  • Patients who receiving S-1 adjuvant chemotherapy
  • Patients who administrated S-1 for more than 7 days

排除标准

  • who using eyedrop medication
  • who has dry eye that tear cannot be sampled

研究者

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

Namju Kim

Professor for clinical department

Seoul National University Bundang Hospital

研究点 (1)

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