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临床试验/NCT05923567
NCT05923567进行中(未招募)不适用

Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
3yr overall survival

研究概览

简要总结

Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6

Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.

排除标准

  • Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels < 9.0 [Lewis antibody-negative patients] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).

结局指标

主要结局

3yr overall survival

时间窗: Survival period from surgery date, 3 years

3-year survival rate for patients who underwent surgery for pancreatic cancer

次要结局

  • 1yr disease free survival(Period without recurrence from the date of surgery, one year)

研究者

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

Hyung Sun Kim

Assoiciate Professor

Gangnam Severance Hospital

研究点 (1)

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