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临床试验/NCT03894384
NCT03894384Unknown不适用

The Value of Serum Trefoil Factor Family 3 (TFF3) in Diagnosis of Gastric Cancer

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker

研究概览

简要总结

Gastric cancer (GC), is a cancer developing from the inner lining of the stomach .The most common cause is infection by the bacterium Helicobacter pylori,which accounts for 60% of cases.

Human pepsinogens (HP) are proenzymes for pepsin; digestive enzymes produced by gastric chief cells, classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer.

The trefoil factor family (TFF) of peptides comprises small (12-22kDa) molecules that are secreted by the mammalian gastro-intestinal tract.Trefoil factor family 3 (TFF3) is a more stable non invasive biomarker of gastric cancer risk even in early gastric cancer.

详细描述

Gastric cancer (GC), is a cancer developing from the inner lining of the stomach.Approximately half of the gastric cancer cases are diagnosed during advanced stages. One of the reasons for this is the invasiveness of esophagogastroduodenoscopy (EGD) screening examinations that leads to patients avoiding necessary tests .

The most common cause is infection by the bacterium Helicobacter pylori (H.pylori),which accounts for 60% of cases.

The development of tools for the early diagnosis of gastric cancer and precancerous lesions of gastric cancer is important for reducing mortality, increasing survival rates, and improving quality of life.

Endoscopy and biopsy are the reference standards for diagnosis and screening of gastric cancer, but their use is limited for population-wide screening due to their invasiveness.Subsequently, it is necessary to identify novel, simple, cost-effective and manipulable screening methods for gastric cancer.

Human pepsinogens (HP) are proenzymes for pepsin, a digestive enzymes produced by gastric chief cells,biochemically and immunochemically classified into two groups: pepsinogen I (PGI) and pepsinogen II (PGII), humen pepsinogens considered promising serological biomarkers for the screening of atrophic gastritis and gastric cancer,serum pepsinogen test provides a valuable method for detecting gastric cancer and atrophic gastritis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Includes all patients presented by gastric cancer with clinical, radiological, laboratory diagnosis and pathological diagnosis.
  • Individuals with benign diseases such as gastric polyps ,leiomyomas, gastric ulcers, atrophic gastritis and gastritis clinical, radiological, laboratory and pathological diagnosis.

排除标准

  • - Previous upper gastrointestinal surgery, patients with gastric cancer that had been received chemotherapy, radiotherapy or surgical treatment.
  • Patients simultaneously presented with a malignancy other than that of the stomach (Breast, pancreatic or colorectal).
  • Pateints with severe systemic co-morbidities such as cardiopulmonary,hepatic and renal diseases

结局指标

主要结局

Diagnostic value of trefoil factor family 3 (TFF3) in serum of gastric cancer as non invasive marker

时间窗: 2 day

Measurement of TFF3 by enzyme linked immunosorbent assay (ELISA) in serum of gastric cancer patients

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

Melouk Ahmed

Director

Assiut University

研究点 (1)

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