Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:14 AM
Study NCT ID:
NCT07332104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Extracellular Vesicle Detection in Gastric Juice Based on Metamaterial Sensing in the Diagnosis of Gastric Cancer and Related Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach 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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-28', 'size': 275811, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-28T05:13', 'hasProtocol': True}, {'date': '2025-12-28', 'size': 161869, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-28T05:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Extracellular vesicles'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-28', 'studyFirstSubmitDate': '2025-12-14', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface plasmon resonance(SPR) detection of extracellular vesicles in gastric juice of patients with gastric cancer has large shift and spectral changes', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'Extracellular vesicles'], 'conditions': ['Gastric Cancer (GC)', 'Gastric Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'After obtaining informed consent from the patients, all the medical history and treatment records of the patients who underwent gastroscopy since the onset of the disease, as well as gastric fluid samples, including laboratory and imaging data, were collected and recorded. The medical history and treatment records and gastric fluid samples were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gastric cancer and non-cancer patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent gastroscopy and treatment at the Endoscopy Center of Beijing Friendship Hospital, Capital Medical University, and received pathological biopsy.\n* Previous gastroscopy suggested the possibility of lesions.\n* No previous history of gastrointestinal cancer.\n\nExclusion Criteria:\n\n* Patients could not cooperate with the examination or had contraindications to endoscopy.\n* Previous history of gastrointestinal tumors, gastrointestinal surgery, physical and chemical injuries of the gastrointestinal tract.\n* Severe bile reflux.\n* Take simethicone and other defoaming agents before examination.\n* Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.'}, 'identificationModule': {'nctId': 'NCT07332104', 'briefTitle': 'The Application of Extracellular Vesicle Detection in Gastric Juice Based on Metamaterial Sensing in the Diagnosis of Gastric Cancer and Related Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'The Application of Extracellular Vesicle Detection in Gastric Juice Based on Metamaterial Sensing in the Diagnosis of Gastric Cancer and Related Diseases', 'orgStudyIdInfo': {'id': 'BFHZS20240020'}, 'secondaryIdInfos': [{'id': 'No. BFHZS20240020', 'type': 'OTHER_GRANT', 'domain': 'the Ethics Committee of Beijing Friendship Hospital, Capital Medical University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'gastric cancer', 'description': 'Patients diagnosed with gastric cancer', 'interventionNames': ['Diagnostic Test: In vitro surface plasmon resonance detection']}], 'interventions': [{'name': 'In vitro surface plasmon resonance detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gastric juice from patients was removed for isolation of extracellular vesicles and surface plasmon resonance detection in vitro', 'armGroupLabels': ['gastric cancer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hao-Su Zhan, Dr.', 'role': 'CONTACT', 'email': '1509082764@qq.com', 'phone': '13565915192'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min Li', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}