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Trial Title:
The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer
NCT ID:
NCT05494359
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophageal cancer
Nitrogen isotope
Diagnosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
The nitrogen isotope
Description:
The nitrogen isotope of various mass in oral gas were detected.
Arm group label:
ESCA group
Arm group label:
Health control
Arm group label:
Reflux esophagitis
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.
Criteria for eligibility:
Study pop:
40 health volunteer； 40 esophageal cancer patients； 40 reflux esophagitis patients
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbo Meng, MD,PhD
Phone:
+8613919177177
Email:
mengwb@lzu.edu.cn
Contact backup:
Last name:
Haitao Yu, MD,PhD
Phone:
+86 13919846787
Email:
yuhaitao7707@163.com
Investigator:
Last name:
Haitao Yu, MD,PhD
Email:
Principal Investigator
Facility:
Name:
Wuwei Tumor Hospital
Address:
City:
Wuwei
Zip:
733099
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Nie, M.D.
Phone:
+8615294333003
Email:
nie.peng2008@163.com
Facility:
Name:
Clinical Research Centre, The Seventh Affiliated Hospital
Address:
City:
Shenzhen
Zip:
518107
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinqiu Yuan, Ph.d
Phone:
+8681206380
Email:
yuanjq5@mail.sysu.edu.cn
Start date:
April 4, 2023
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Agency class:
Other
Source:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494359
