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临床试验/NCT04999072
NCT04999072Unknown不适用

Carbohydrate Antigen 19-9 Plus Carcinoembryonic Antigen for Prognosis in Colorectal Cancer

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 4,972 人开始时间: 2020年4月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,972
试验地点
1
主要终点
Relapse free survival

研究概览

简要总结

4,972 patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital were retrospectively reviewed.

CA19-9 is a valuable prognostic and diagnostic marker for CRC when used adjunctively with CEA and can be a supplementary marker with CEA to improve sensitivity, especially with elevated preoperative CA19-9.

详细描述

Introduction

Carcinoembryonic antigen (CEA) is a main prognostic marker and can detect colorectal cancer (CRC) recurrence, but it has low sensitivity. Carbohydrate antigen 19-9 (CA19-9) can be used as a supplemental tumour marker along with CEA. This study investigated the utility of preoperative and follow-up serum CA19-9 assessment for CRC.

Materials and Methods

We retrospectively assessed 4,972 patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital. Data on demographics, preoperative and follow-up CEA and CA19-9 levels, recurrence, and survival were obtained and analysed with respect to tumour marker levels to ascertain their prognostic and diagnostic values.

Results: The 5-year relapse-free survival rates were 72.2±0.8%, 52.5±2.2%, 55.5±3.2%, and 32.1±2.3% in the normal CEA and CA19-9, high CEA, high CA19-9, and high CEA and high CA19-9 groups, respectively (all p<0.001). Patients whose elevated CEA or CA19-9 reduced to normal had better survival outcomes than those with postoperatively elevated levels. Elevated follow-up CA19-9 and CEA levels were related to higher incidences of distant metastasis (CA19-9: 14.0% vs. 23.1%, p=0.004, CEA: 12.6% vs. 30.1%, p<0.001) but not with local recurrence. Combined follow-up CEA and CA19-9 increased the sensitivity for recurrence to 31.4%, with a 5% difference compared with CEA alone. In the subgroup with high preoperative CA19-9 levels, sensitivity increased by 18.2% overall.

Conclusion: CA19-9 is a valuable prognostic and diagnostic marker for CRC when used adjunctively with CEA and can be a supplementary marker with CEA to improve sensitivity, especially with elevated preoperative CA19-9.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients who underwent surgery for primary CRC between January 2004 and December 2015 at Seoul National University Hospital

排除标准

  • The patients with missing data for preoperative and follow-up tumour markers

结局指标

主要结局

Relapse free survival

时间窗: 5-year

Recurrence and death was the event for relapse free survival

次要结局

未报告次要终点

研究者

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

Min Jung Kim

Assistant Professor

Seoul National University Hospital

研究点 (1)

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