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

Esophageal Cancer Clinical Trial

— N  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494359
• Other study ID #: Nitrogen element
• Status: Recruiting
• Start date: April 4, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D. Ph.D
• Phone: +8613919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Diagnostic Test:
• The nitrogen isotope
The nitrogen isotope of various mass in oral gas were detected.

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu
China	Clinical Research Centre, The Seventh Affiliated Hospital	Shenzhen	Guangdong
China	Wuwei Tumor Hospital	Wuwei	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The differentiation type of the tumor	The type of differentiation, low, moderate or high by histology	1 week
Secondary	The stage of the cancer	According to the primary tumor, regional nodes, metastasis classification	1 week