Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 4:27 AM
Study NCT ID:
NCT05494359
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2022-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2022-08-07', 'studyFirstSubmitQcDate': '2022-08-07', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'The number of 15 Nitrogen, 14 Nitrogen, 16 Nitrogen, 28 Nitrogen, 29 Nitrogen, 30 Nitrogen.', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'The area under curve value of exhaled mass nitrogen components for esophageal cancer.', 'timeFrame': '1 week', 'description': '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) .'}, {'measure': 'The sensitivity and specificity of exhaled mass nitrogen components for esophageal cancer.', 'timeFrame': '1 week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The differentiation type of the tumor.', 'timeFrame': '1 week', 'description': 'The type of differentiation, low, moderate or high by histology'}, {'measure': 'The stage of the cancer.', 'timeFrame': '1 week', 'description': 'According to the primary tumor, regional nodes, metastasis classification'}, {'measure': 'The accuracy of exhaled mass nitrogen components for the diagnosis of esophageal cancer stages and invasion.', 'timeFrame': '1 week', 'description': '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).'}, {'measure': '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.', 'timeFrame': '1 week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal cancer', 'Nitrogen mass-charge ratio abundances (NMARs)', 'Diagnosis'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '28566705', 'type': 'RESULT', '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.'}, {'pmid': '34256713', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the diagnostic value of various nitrogen components in oral gas for esophagus cancer (ESCA) .', 'detailedDescription': '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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 esophageal cancer patients; 40 reflux esophagitis patients; 40 health volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* 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).\n* 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.\n\nExclusion Criteria:\n\n* Esophageal or gastric surgery\n* History of previous upper abdominal surgery\n* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection\n* History of other malignant disease within past five years\n* History of previous neoadjuvant chemotherapy or radiotherapy\n* History of unstable angina or myocardial infarction within past six months\n* History of cerebrovascular accident within past six months\n* Requirement of simultaneous surgery for other disease\n* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by cancer\n* Pregnant women or breastfeeding\n* Unwillingness or inability to consent for the study\n* Severe mental disorder\n* Unstable vital signs Coagulation dysfunction (INR\\>1.5)\n* Low peripheral blood platelet or using anti coagulation drugs\n* Long-term Chinese medicine treatment of unknown drug nature"}, 'identificationModule': {'nctId': 'NCT05494359', 'briefTitle': 'The Diagnostic Value of Nitrogen Element (N) in Esophagus Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'The Diagnostic Value of Various Mass Nitrogen Components Excreting for Oral Gas in Esophagus Cancer', 'orgStudyIdInfo': {'id': 'Nitrogen element'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESCA group', 'description': '40 patients of ESCA were included through the diagnosis of gastroscopic biopsy positive.\n\nAge, 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.', 'interventionNames': ['Diagnostic Test: The nitrogen isotope']}, {'label': 'Health control', 'description': '40 healthy people who experienced negative gastroscopy and tumor biomarkers were included as healthy control.\n\nAge, gender, gastroscope, tumor biomarkers and other laboratory test results have been collected.', 'interventionNames': ['Diagnostic Test: The nitrogen isotope']}, {'label': 'Reflux esophagitis', 'description': '40 patients of reflux esophagitis were included. Age, gender, tumor markers and other laboratory test indicators, gastroscope and pathological examinations results have been collected.', 'interventionNames': ['Diagnostic Test: The nitrogen isotope']}], 'interventions': [{'name': 'The nitrogen isotope', 'type': 'DIAGNOSTIC_TEST', 'description': 'The nitrogen mass-charge ratio abundances (NMAs) and NMA ratios (NMARs) The nitrogen components of various m/z values in oral gas were detected.', 'armGroupLabels': ['ESCA group', 'Health control', 'Reflux esophagitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '733099', 'city': 'Wuwei', 'state': 'Gansu', 'country': 'China', 'facility': 'Wuwei Tumor Hospital', 'geoPoint': {'lat': 37.92672, 'lon': 102.63202}}, {'zip': '518107', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Clinical Research Centre, The Seventh Affiliated Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individuals may be reluctant to divulge health information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}