Clinical trial NCT05494359: The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer
Official title: The Diagnostic Value of Various Mass Nitrogen Isotope Excreting for Oral Gas in Esophagus Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Esophageal cancer
Nitrogen isotope
Diagnosis
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 health volunteer； 40 esophageal cancer patients； 40 reflux esophagitis patients

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 week
measure: The number of 15 Nitrogen, 14 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen
timeFrame: 1 week
Secondary outcomes:
measure: The differentiation type of the tumor
timeFrame: 1 week
measure: The stage of the cancer
timeFrame: 1 week
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
city: Wuwei
country: China
facility: Wuwei Tumor Hospital
state: Gansu
city: Shenzhen
country: China
facility: Clinical Research Centre, The Seventh Affiliated Hospital
state: Guangdong
Study officials:
References:
citation: 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.
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 Jul 13;21(1):805. doi: 10.1186/s12885-021-08489-x.