Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT06109805
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Only metabolites will be detected and analyzed in this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1706}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma metabolite content', 'timeFrame': 'Before receiving treatment for gastric cancer', 'description': 'The outcome will be tested by metabolomics detection technology based on mass spectrometry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.', 'detailedDescription': 'Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information.\n\nSecondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy.\n\nUltimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population included a range of subjects with gastric and non-gastric cancer, including patients with benign gastric disease and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination.\n* Collection of plasma samples prior to surgical treatment.\n* Availability of complete clinical data.\n\nExclusion Criteria:\n\n* Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.\n* Coexistence of other systemic tumors.\n* Absence of plasma sample collection before surgical treatment.\n* Incomplete clinical data.\n* Pregnancy status.'}, 'identificationModule': {'nctId': 'NCT06109805', 'briefTitle': 'Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics', 'orgStudyIdInfo': {'id': 'BFHHZML20230010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric cancer group', 'description': 'Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer', 'interventionNames': ['Other: Gastric cancer']}, {'label': 'Non-gastric cancer group', 'description': 'Patients diagnosed with benign gastric diseases or healthy controls'}], 'interventions': [{'name': 'Gastric cancer', 'type': 'OTHER', 'description': 'Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer', 'armGroupLabels': ['Gastric cancer group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College of HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Li Min, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Science and Technology Department', 'investigatorFullName': 'Min Li', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}