Esophageal CancerNCT05494359
The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer
An observational study of Esophageal Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites in China.
Trial summary
The purpose of this study is to determine the diagnostic value of various nitrogen components in oral gas for esophagus cancer (ESCA) . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The nitrogen isotope
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 4 Apr 2023to 16 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 esophageal cancer patients; 40 reflux esophagitis patients; 40 health volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
Clinical Research Centre, The Seventh Affiliated Hospital
Shenzhen, Guangdong, 518107
Wuwei Tumor Hospital
Wuwei, Gansu, 733099
About this study
Official title: The Diagnostic Value of Various Mass Nitrogen Components Excreting for Oral Gas in Esophagus Cancer
The purpose of this study is to determine the diagnostic value of various nitrogen components in oral gas for esophagus cancer (ESCA) .
Read the 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
- Being tested
- The nitrogen isotope
- Keywords
- Esophageal cancer, Nitrogen mass-charge ratio abundances (NMARs), Diagnosis
- Medical subject headings
- Esophageal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The nitrogen isotopeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: The nitrogen isotope | |
| 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. Receives: Diagnostic Test: The nitrogen isotope | |
| 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. Receives: Diagnostic Test: The nitrogen isotope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, 28 N/ 16 N , 29 N/16 N, 30 N/16 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, 390-500 , 700-960, 5.1-7.3, 1.7-1.9, 0.009-0.011, 0.007-0.08, respectively.
Measured: 1 week
The number of 15 Nitrogen, 14 Nitrogen, 16 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, 33000-60000, 4090000-4630000, 7100000-8200000, 520000-610000, respectively.
Measured: 1 week
The area under curve value of exhaled mass nitrogen components for esophageal cancer.
Area under curve is the area under the Receiver Operating Characteristic (ROC) curve, serving as a crucial metric for evaluating the performance of classification exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) .
Measured: 1 week
The sensitivity and specificity of exhaled mass nitrogen components for esophageal cancer.
The sensitivity and specificity will be determined by comparing the result to the clinical gold standard gastroscope. They reflect the reliability of the test results.
Measured: 1 week
Secondary outcomes (4)
The differentiation type of the tumor.
The type of differentiation, low, moderate or high by histology
Measured: 1 week
The stage of the cancer.
According to the primary tumor, regional nodes, metastasis classification
Measured: 1 week
The accuracy of exhaled mass nitrogen components for the diagnosis of esophageal cancer stages and invasion.
The ROC curve, sensitivity and specificity of various representative exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) for detecting early-stage (I and II ) and invasion (T1/T2).
Measured: 1 week
The negative and positive predictive value of exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) for detecting ESCA and different subgroups ESCA.
The positive and negative predictive value will be determined based on true positive and false positive, and true negative and false negative, respectively. They reflect the reliability of the test results.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start4 Apr 2023
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494359
- Sponsor's protocol ID
- Nitrogen element
- Status last verified
- Jul 2025
- First submitted
- 7 Aug 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individuals may be reluctant to divulge health information
Publications
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.
PubMed 28566705Straub 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.
PubMed 34256713
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Various Mass Nitrogen Components Excreting for Oral Gas in Esophagus Cancer
- ClinicalTrials.gov ID
- NCT05494359
- Acronym / sponsor ID
- Nitrogen element
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Nitrogen mass-charge ratio abundances (NMARs), Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESCA group | – | Diagnostic Test: The nitrogen isotope40 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. |
| Health control | – | Diagnostic Test: The nitrogen isotope40 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. |
| Reflux esophagitis | – | Diagnostic Test: The nitrogen isotope40 patients of reflux esophagitis were included. Age, gender, tumor markers and other laboratory test indicators, gastroscope and pathological examinations results have been collected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 esophageal cancer patients; 40 reflux esophagitis patients; 40 health volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The nitrogen isotopeThe nitrogen mass-charge ratio abundances (NMAs) and NMA ratios (NMARs) The nitrogen components of various m/z values in oral gas were detected. | Diagnostic test | ESCA group, Health control, Reflux esophagitis |
Primary outcome
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, 28 N/ 16 N , 29 N/16 N, 30 N/16 N,29 N/28 N,30 N/18 N,30 N/29 N ratio.
Time frame: 1 week
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, 390-500 , 700-960, 5.1-7.3, 1.7-1.9, 0.009-0.011, 0.007-0.08, respectively.
The number of 15 Nitrogen, 14 Nitrogen, 16 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen.
Time frame: 1 week
The normal 15 Nitrogen, 14 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen reference interval were 98000-140000, 98000-140000, 33000-60000, 4090000-4630000, 7100000-8200000, 520000-610000, respectively.
The area under curve value of exhaled mass nitrogen components for esophageal cancer.
Time frame: 1 week
Area under curve is the area under the Receiver Operating Characteristic (ROC) curve, serving as a crucial metric for evaluating the performance of classification exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) .
The sensitivity and specificity of exhaled mass nitrogen components for esophageal cancer.
Time frame: 1 week
The sensitivity and specificity will be determined by comparing the result to the clinical gold standard gastroscope. They reflect the reliability of the test results.
4 secondary outcomes
The differentiation type of the tumor.
Time frame: 1 week
The stage of the cancer.
Time frame: 1 week
The accuracy of exhaled mass nitrogen components for the diagnosis of esophageal cancer stages and invasion.
Time frame: 1 week
The negative and positive predictive value of exhaled nitrogen indicators (nitrogen mass-charge ratio abundances, and nitrogen mass-charge ratio abundances ratios) for detecting ESCA and different subgroups ESCA.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Results publication: PubMed 28566705Krishnamurthy 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.
- Results publication: PubMed 34256713Straub 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.
- Individual participant dataSharing planned: Undecided. Individuals may be reluctant to divulge health information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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, 28 N/ 16 N , 29 N/16 N, 30 N/16 N,29 N/28 N,30 N/18 N,30 N/29 N ratio. (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.