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临床试验/NCT03724604
NCT03724604Unknown不适用

A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
202
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The incidence and mortality rate of lung cancer is the highest in the world. Current studies have found that tumor markers, inflammatory or nutritional indicators have a good predictive value for the prognosis of patients with non-small cell lung cancer (NSCLC). Neuron specific enolase (NSE) and serum albumin (Alb) are important indicators for monitoring tumor progression and nutritional status in lung cancer patients, respectively. Previous studies suggested that the higher the NSE, the worse prognosis of NSCLC patients, while the lower the Alb, the worse the prognosis of patients with malignant tumors. Through a retrospective study, the investigators found that NAR (NSE Alb Ratio) was higher and prognosis was poorer in patients undergoing NSCLC surgery. This is better than the previous assessment indicators PLR (platelet to lymphocyte ratio), NLR (neutrophil to lymphocyte ratio), AGR (albumin to globulin ratio), NAR can better assess prognosis. Therefore, on the basis of the previous retrospective analysis, the optimal NAR cut-off value was calculated according to ROC curve, and the value was grouped into multi-center prospective cohort study, and the relationship between NAR and other clinical indicators was studied by chi-square test. Univariate and multivariate analysis of Cox proportional hazard regression model was used to determine the prognostic factors. Finally, NSCLC patients were stratified according to tumor stage and pathological classification, and the differences of survival time between high NAR group and low NAR group were compared again under different stages and types, and the different stages of NAR in NSCLC patients were further analyzed. The clinical significance of typing. By exploring and validating the relationship between NAR and the prognosis of NSCLC patients, the investigators try to establish a new prognostic index. Obviously, it has important value for clinical application.

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

入选标准

  • (1) pathological diagnosis of non-small cell lung cancer
  • (2) 18-70 years of age and no gender restriction.
  • (3) patients who were admitted for the first time and underwent routine blood tests, three lung cancer and liver function tests.

排除标准

  • (1) pregnant or lactating women
  • (2) patients with other malignancies at the same time
  • (3) patients with acute and chronic inflammation, autoimmune diseases, and patients with obvious liver and renal insufficiency.
  • (4) patients with incomplete clinical and pathological data.

结局指标

主要结局

Overall survival

时间窗: 2 years.

The time from randomization to death due to any cause. The last follow-up time is usually calculated as the time of death for those who have been lost before death.

次要结局

  • Disease-free survival(2 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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