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

NCT ID: NCT05494359

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2024-11-16

Brief Summary

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

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

The nitrogen isotope

Intervention Type: 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.

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.

The nitrogen isotope

Intervention Type: 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.

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.

The nitrogen isotope

Intervention Type: 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.

Interventions

The nitrogen isotope

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Wenbo Meng

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Wuwei Tumor Hospital

Wuwei, Gansu, China

Clinical Research Centre, The Seventh Affiliated Hospital

Shenzhen, Guangdong, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 28566705 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34256713 (View on PubMed)

Other Identifiers

Nitrogen element

Identifier Type: -

Identifier Source: org_study_id