The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the diagnostic value of various nitrogen isotopes(N) in oral gas for esophagus cancer (ESCA) .

Detailed Description
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Less effective diagnostic markers for ESCA can be used in present. Nitrogen elements include a variety of nitrogen isotopes with various mass. 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 isotope excreting for oral gas for ESCA.

Official Title
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The Diagnostic Value of Various Mass Nitrogen Isotope Excreting for Oral Gas in Esophagus Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Diagnostic Test: The nitrogen isotope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Esophageal cancer patient Reflux esophagitis patient 18-80 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESCA group<br>40 patients of ESCA were included through the diagnosis of gastroscopic biopsy positive. Age, gender, esophageal cancer staging, tumor biomarkers and other laboratory test indicators, CT and other imaging examinations results, gastroscope and pathological examinations results have been collected. | Diagnostic Test: The nitrogen isotope<br>* The nitrogen isotope of various mass in oral gas were detected.<br>|
| Health control<br>40 healthy people who experienced negative gastroscopy and tumor biomarkers were included as healthy control. Age, gender, gastroscope, tumor biomarkers and other laboratory test results have been collected. | Diagnostic Test: The nitrogen isotope<br>* The nitrogen isotope of various mass in oral gas were detected.<br>|
| Reflux esophagitis<br>40 patients of reflux esophagitis were included. Age, gender, tumor markers and other laboratory test indicators, gastroscope and pathological examinations results have been collected. | Diagnostic Test: The nitrogen isotope<br>* The nitrogen isotope of various mass in oral gas were detected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 29 N/28 N,30 N/18 N,30 N/29 N ratio | 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, 1.7-1.9, 0.009-0.011, 0.007-0.08, respectively. | 1 week | 
| The number of 15 Nitrogen, 14 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen | The normal 15 Nitrogen, 14 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen reference interval were 98000-140000, 98000-140000, 4090000-4630000, 7100000-8200000, 520000-610000, respectively. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differentiation type of the tumor | The type of differentiation, low, moderate or high by histology | 1 week | 
| The stage of the cancer | According to the primary tumor, regional nodes, metastasis classification | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Nitrogen isotope, Diagnosis