The Diagnostic Value of Various Mass Nitrogen Components Excreting for Oral Gas in Esophagus Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- 15 Nitrogen/14 Nitrogen (15 N/14 N),28 N/14 N, 29 N/14 N,30 N/14 N, 28 N/ 15 N , 29 N/15 N,30 N/15 N, 28 N/ 16 N , 29 N/16 N, 30 N/16 N,29 N/28 N,30 N/18 N,30 N/29 N ratio.
研究概览
简要总结
The purpose of this study is to determine the diagnostic value of various nitrogen components in oral gas for esophagus cancer (ESCA) .
详细描述
Less effective diagnostic markers for ESCA can be used in present. Nitrogen elements include a variety of nitrogen components (each corresponding to a specific mass-charge ratio [m/z] value). Stable nitrogen isotope ratios 15 Nitrogen/14 Nitrogen (15 N/14 N) are of particular advantage to understand the metabolic state of cancer cells, since most biochemical reactions involve transfer of nitrogen. Cancerous cells can recycle metabolic ammonium for their growth . The recycling of this ammonium with a low nitrogen isotope ratio (15 N/14 N) may cause cancer tissue to have lower 15 N/14 N than surrounding healthy tissue, and it could diagnose malignancy as well as an avenue for investigation of cancer metabolism.
However, the relationship and diagnostic value between nitrogen excretion from oral gas and ESCA remains unclear. The purpose of this study is to analyze the diagnostic value of various mass nitrogen components excreting for oral gas for ESCA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Esophageal cancer patients (Case): Subject diagnosed with ESCA based on typical clinical symptoms, endoscopic observation of esophageal lesions, and histopathological examination of biopsy specimens obtained from the lesion sites.
- •Reflux esophagitis patients (Case control): Subject diagnosed diagnosed with reflux esophagitis based on typical clinical symptoms (e.g., heartburn and acid regurgitation) and endoscopic evidence of esophageal mucosal injury classified according to the Los Angeles classification system (Grade A: mucosal breaks ≤5 mm in length; Grade B: mucosal breaks >5 mm in length but not confluent; Grade C: confluent mucosal breaks involving <75% of the esophageal circumference; Grade D: confluent mucosal breaks involving ≥75% of the esophageal circumference).
- •Health people: (Healthy control): no history of malignant tumors within the past five years, normal findings on gastroscopy, with no evidence of esophageal or gastric lesions, no history of gastrointestinal diseases such as gastroesophageal reflux disease (GERD) or Barrett's esophagus, blood counts, tumor biomarkers, and liver and kidney function tests within normal ranges.
排除标准
- •Esophageal or gastric surgery
- •History of previous upper abdominal surgery
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •History of other malignant disease within past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by cancer
- •Pregnant women or breastfeeding
- •Unwillingness or inability to consent for the study
- •Severe mental disorder
- •Unstable vital signs Coagulation dysfunction (INR>1.5)
- •Low peripheral blood platelet or using anti coagulation drugs
- •Long-term Chinese medicine treatment of unknown drug nature
结局指标
主要结局
15 Nitrogen/14 Nitrogen (15 N/14 N),28 N/14 N, 29 N/14 N,30 N/14 N, 28 N/ 15 N , 29 N/15 N,30 N/15 N, 28 N/ 16 N , 29 N/16 N, 30 N/16 N,29 N/28 N,30 N/18 N,30 N/29 N ratio.
时间窗: 1 week
The normal "Nitrogen" ratio reference interval were 0.18-0.20, 69-78, 122-143, 0.9-1.1, 340-410, 602-747, 4.4-5.6, 390-500 , 700-960, 5.1-7.3, 1.7-1.9, 0.009-0.011, 0.007-0.08, respectively.
The number of 15 Nitrogen, 14 Nitrogen, 16 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen.
时间窗: 1 week
The normal 15 Nitrogen, 14 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen reference interval were 98000-140000, 98000-140000, 33000-60000, 4090000-4630000, 7100000-8200000, 520000-610000, respectively.
The area under curve value of exhaled mass nitrogen components for esophageal cancer.
时间窗: 1 week
Area under curve is the area under the Receiver Operating Characteristic (ROC) curve, serving as a crucial metric for evaluating the performance of classification exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) .
The sensitivity and specificity of exhaled mass nitrogen components for esophageal cancer.
时间窗: 1 week
The sensitivity and specificity will be determined by comparing the result to the clinical gold standard gastroscope. They reflect the reliability of the test results.
次要结局
- The differentiation type of the tumor.(1 week)
- The stage of the cancer.(1 week)
- The accuracy of exhaled mass nitrogen components for the diagnosis of esophageal cancer stages and invasion.(1 week)
- The negative and positive predictive value of exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) for detecting ESCA and different subgroups ESCA.(1 week)
研究者
Wenbo Meng
Professor of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province