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

Last updated: July 9, 2025
Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Overall Status: Completed

Phase

N/A

Condition

Esophageal Disorders

Esophageal Cancer

Digestive System Neoplasms

Treatment

The nitrogen isotope

Clinical Study ID

NCT05494359
Nitrogen element
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Esophageal cancer patients (Case): Subject diagnosed with ESCA based on typicalclinical symptoms, endoscopic observation of esophageal lesions, andhistopathological examination of biopsy specimens obtained from the lesion sites.

  • Reflux esophagitis patients (Case control): Subject diagnosed diagnosed with refluxesophagitis based on typical clinical symptoms (e.g., heartburn and acidregurgitation) and endoscopic evidence of esophageal mucosal injury classifiedaccording to the Los Angeles classification system (Grade A: mucosal breaks ≤5 mm inlength; 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 pastfive years, normal findings on gastroscopy, with no evidence of esophageal orgastric lesions, no history of gastrointestinal diseases such as gastroesophagealreflux disease (GERD) or Barrett's esophagus, blood counts, tumor biomarkers, andliver and kidney function tests within normal ranges.

Exclusion

Exclusion Criteria:

  • Esophageal or gastric surgery

  • History of previous upper abdominal surgery

  • History of previous gastrectomy, endoscopic mucosal resection or endoscopicsubmucosal 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) causedby 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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: The nitrogen isotope
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
November 16, 2024

Study Description

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.

Connect with a study center

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Wuwei Tumor Hospital

    Wuwei, Gansu 733099
    China

    Site Not Available

  • Clinical Research Centre, The Seventh Affiliated Hospital

    Shenzhen, Guangdong 518107
    China

    Site Not Available

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