跳至主要内容
临床试验/CTRI/2022/10/046470
CTRI/2022/10/046470尚未招募不适用

Comparing clinical utility of serum CA 72-4 level with CEA and CA 19-9 in monitoring gastric cancer treatment.

Abbott India Ltd1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
246
试验地点
1
主要终点
Sensitivity, specificity and positive and negative predictive value of serum CA 72-4, CEA and CA 19-9 will be assessed in the diagnosis of gastric cancer recurrence, at the end of follow-up period of 2 years

研究概览

简要总结

Gastric cancer ranks among the top 5 most common cancers. Notorious for a high postoperative recurrence rate, it is the main reason for death in gastric cancer patients. Serum tumor markers are useful in assessing prognosis and tailoring treatments in various cancers. Among the available tumor markers, carcinoembryonic antigen (CEA) and CA19-9 are both widely used in the follow-up of patients with gastrointestinal malignancies. Various studies which evaluated CA 72-4 as a relatively new tumor marker for gastric cancer and compared its clinical utility with CEA and CA 19-9 observed good specificity. Studies also noted that, it could serve as a prognostic tool, predict recurrent or metastatic disease, and help in post therapeutic follow-up.

The purpose of our study is to monitor treatment of gastric cancer patients with serum CA 72-4 levels in order to assess the response and compare its clinical utility with serum CEA and CA 19-9 levels in monitoring disease progression.

All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up to monitor the treatment and assess the disease progression.

We expect serum CA 72-4 to be a better tumor marker as compared to CEA and CA 19-9 in understanding the prognosis and identifying recurrence at an early stage, thereby improving the survival rate in gastric cancer patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Histopathology confirmed, newly diagnosed and previously untreated gastric cancer patients.

排除标准

  • Past or present history of any other cancer, gastric surgery treatment history, severe functional impairment of important organs such as the heart, brain, lung, kidney or liver.

结局指标

主要结局

Sensitivity, specificity and positive and negative predictive value of serum CA 72-4, CEA and CA 19-9 will be assessed in the diagnosis of gastric cancer recurrence, at the end of follow-up period of 2 years

时间窗: All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up to monitor the treatment and assess the disease progression.

次要结局

  • Serum CA 72-4, CEA and CA 19-9 levels will be correlated with the imaging performed at baseline and during follow-up as per the existing disease management protocol and routine practice to check for gastric cancer recurrence.(All the patients who are newly diagnosed of gastric cancer and planned to receive treatment as per existing disease management protocol will be followed up for 2 year and their serum tumor marker levels will be analyzed at every follow up and correlated with imaging findings wherever applicable, to monitor the treatment and assess the disease progression.)

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (1)

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