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

NCT05494359 | Completed

• 1 other identifier: Nitrogen element
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the diagnostic value of various nitrogen components in oral gas for esophagus cancer (ESCA) .

Conditions

Esophageal Cancer

Keywords

Esophageal cancer; Nitrogen mass-charge ratio abundances (NMARs); Diagnosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  1 week

• The number of 15 Nitrogen, 14 Nitrogen, 16 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, 33000-60000, 4090000-4630000, 7100000-8200000, 520000-610000, respectively.

  1 week

• The area under curve value of exhaled mass nitrogen components for esophageal cancer.

  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) .

  1 week

• The sensitivity and specificity of exhaled mass nitrogen components for esophageal cancer.

  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.

  1 week

Secondary Outcomes (4)

• 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

Study Arms (3)

ESCA group

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

Health control

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

Reflux esophagitis

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

Interventions

The nitrogen isotope DIAGNOSTIC_TEST

The nitrogen mass-charge ratio abundances (NMAs) and NMA ratios (NMARs) The nitrogen components of various m/z values in oral gas were detected.

ESCA group; Health control; Reflux esophagitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 esophageal cancer patients; 40 reflux esophagitis patients; 40 health volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (3)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Wuwei Tumor Hospital

Wuwei, Gansu, 733099, China

Location

Clinical Research Centre, The Seventh Affiliated Hospital

Shenzhen, Guangdong, 518107, China

Location

Related Publications (2)

• Krishnamurthy RV, Suryawanshi YR, Essani K. Nitrogen isotopes provide clues to amino acid metabolism in human colorectal cancer cells. Sci Rep. 2017 May 31;7(1):2562. doi: 10.1038/s41598-017-02793-y.

  PMID: 28566705 RESULT

• Straub M, Sigman DM, Auderset A, Ollivier J, Petit B, Hinnenberg B, Rubach F, Oleynik S, Vozenin MC, Martinez-Garcia A. Distinct nitrogen isotopic compositions of healthy and cancerous tissue in mice brain and head&neck micro-biopsies. BMC Cancer. 2021 Jul 13;21(1):805. doi: 10.1186/s12885-021-08489-x.

  PMID: 34256713 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: April 4, 2023
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (3)