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临床试验/NCT02821949
NCT02821949已完成不适用

Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年12月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
PCT value performed just before the first chemotherapy treatment

研究概览

简要总结

Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. This biological evaluation is based on the CRP rate. Lots of infections may occur in this situation and could reduce by three the patient's life duration. However it is very important to make as early as possible a correct diagnosis of infection. CRP rate is classically higher for those patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and reliable method to use. So the investigators decided to include each new patient with NSCLC stage IV coming for his first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. A new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.

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

  • •Patient with stage IV NSCLC, hospitalized for his first seance of chemotherapy
  • •Medical conditions permitting chemotherapy
  • •Informed consent signed
  • •Patient covered by social insurance

排除标准

  • •Patient with small cell lung cancer
  • •Patients with NSCLC stage I, II or III of the Tumor Node Metastasis classification
  • •Patient with stage IV NSCLC, who received prior treatment (radiotherapy, chemotherapy ...)
  • •Patient with infection (on clinical and paraclinical criteria) not compatible with the administration of the first seance of chemotherapy.
  • •Pregnant or breastfeeding women Private Patient freedom or in a position to judicial protection (guardianship)

研究组 & 干预措施

Patients

Patients with Non Small Cells Lung Cancer PCT dosage

干预措施: PCT dosage (Biological)

结局指标

主要结局

PCT value performed just before the first chemotherapy treatment

时间窗: Day 1

Sampling at the first chemotherapy and each infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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