Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT05058768
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2021-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine or alveolar lavage fluid samples of the experimental group and the control group were reserved for omics sequencing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the omics differences of blood samples between the experimental and control groups', 'timeFrame': 'one year', 'description': "Collected separately in the experimental group and the control group participants' blood as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research ."}, {'measure': 'Compare the omics differences of urine samples between the experimental and control groups', 'timeFrame': 'one year', 'description': "Collected separately in the experimental group and the control group participants' urine as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research ."}], 'secondaryOutcomes': [{'measure': 'Compare the omics differences of alveolar lavage fluid samples between the experimental and control groups', 'timeFrame': 'one year', 'description': "Collected separately in the experimental group and the control group participants' alveolar lavage fluid as a specimen, It is used to obtain exosomes and perform omics sequencing, to obtain the histopathological differences of exosomes between experimental and control groups, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research ."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lung Injury']}, 'descriptionModule': {'briefSummary': 'The exosomes in the experimental group and the control group were sequenced to find the difference of the two groups, providing a basis for subsequent basic research.', 'detailedDescription': 'This study is an observational study, mainly collected by infection, trauma, burns and other non cardiac causes without any related comprehensive character drug treatment of acute respiratory distress (ARDS) in patients with blood, urine or alveolar lavage fluid specimens, used to extract exosomes for omics sequencing, relevant histomorphic variations in exosomes of this disease were obtained, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The experimental group was patients with acute lung injury, which was caused by various direct and indirect injury factors of alveolar epithelial cells and capillary endothelial cells, resulting in diffuse pulmonary interstitial and alveolar edema, resulting in acute hypoxic respiratory insufficiency. The control group was healthy subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria of experimental group:\n\n* Signed informed consent voluntarily;\n* Age: \\>18 years old, gender: no restrictions ;\n* Patients with known clinical manifestations of respiratory impairment or new/aggravated respiratory symptoms diagnosed within one week of onset according to the Berlin definition guidelines.\n\nControl group inclusion criteria:\n\n* Age ≥18 years old (including 18 years old), male and female;\n* Male weight ≥50 kg, female weight ≥45kg, and body mass index (BMI) between 19 and 26(inclusive), BMI= weight (kg)/ height (㎡);\n* No smoking, alcohol addiction, no history of drug abuse;\n* No diabetes, asthma, copd, chronic renal insufficiency and other basic diseases; No history of major diseases or infectious diseases (including hepatitis B, hepatitis C, HIV, syphilis);\n* Those who have not taken drugs recently.\n\nExclusion Criteria:\n\nExclusion criteria of experimental group:\n\n* Patients with diabetes, chronic renal insufficiency, malignant tumors and other basic diseases;\n* severe malnutrition;\n* Pregnant or lactating women;\n* The researcher judged that he was not suitable to participate in this study.\n\nExclusion criteria for the control group:\n\n* pregnant or lactation women;\n* severe malnutrition;\n* The researcher judged that he was not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05058768', 'briefTitle': 'Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Exosomes in Urine, Blood, and Alveolar Lavage Fluid From Patients With Acute Respiratory Distress Syndrome (ADRS) Were Sequenced by Omics', 'orgStudyIdInfo': {'id': 'NFEC-2021-143'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'Healthy people served as the control group'}, {'label': 'experimental group', 'description': 'Patients with acute lung injury were treated as the experimental group.', 'interventionNames': ['Diagnostic Test: The lungs causes and extrapulmonary factors']}], 'interventions': [{'name': 'The lungs causes and extrapulmonary factors', 'type': 'DIAGNOSTIC_TEST', 'description': 'Acute lung injury due to internal and external pulmonary causes can be used as intervention items in this study, and intervention items can be excluded according to inclusion criteria and exclusion criteria.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhuping zheng, bachelor', 'role': 'CONTACT', 'email': 'zhengzhuping007@163.com', 'phone': '18680263256'}], 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'zhuping M zheng, bachelor', 'role': 'CONTACT', 'email': 'zhengzhuping007@163.com', 'phone': '18680263256'}], 'overallOfficials': [{'name': 'linzhong yu, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}