Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-04-16 @ 4:03 AM
Study NCT ID:
NCT02756559
Status:
UNKNOWN
Last Update Posted:
2016-05-02
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-29', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '28 days after admitted to ICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis', 'microRNAs'], 'conditions': ['T Lymphocyte Disorder']}, 'descriptionModule': {'briefSummary': 'Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in sepsis. The present research further study the regulatory mechanism of those miRNAs in lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a, miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new targets for sepsis treatment.', 'detailedDescription': "Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU) between July 2014 to March 2015. Septic patients were divided into sepsis, severe sepsis and septic shock according to the diagnostic criteria. Peripheral white blood cells were sorted into monocytes, lymphocytes and neutrophils by using flow cytometry (Flow Cytometry, FCM). Jurkat T cell lines were purchased from Chinese Academy of Medical Sciences Institute of basic medical sciences. miRNAs agomirs and antagonists were used to establish miR-223, miR-15a, miR-16 overexpression and knock-out transient transfection cell lines. Western blot was used to detect difference expression of protein expression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU),within 24 hours admitted into ICU.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Sepsis\n* Agree with this study\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Died within 24 hours\n* Combined with HIV infection\n* Agranulocytosis'}, 'identificationModule': {'nctId': 'NCT02756559', 'briefTitle': 'MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'orgStudyIdInfo': {'id': 'S2015-068-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis, severe sepsis and septic shock', 'description': 'Septic patients were divided into sepsis, severe sepsis and septic shock'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Liu, Principal Investigator', 'role': 'CONTACT', 'email': 'liudan_nkdx@163.com', 'phone': '+86 13920701949'}, {'name': 'Lixin Xie, Clinical Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dan Liu, Principal Investigator', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Chinese People's Liberation Army General Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dan Liu, Principal Investigator', 'role': 'CONTACT', 'email': 'liudan_nkdx@163.com', 'phone': '+86 13920701949'}], 'overallOfficials': [{'name': 'Lixin Xie, Clinical Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lixin Xie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Lixin Xie', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}