Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT03296761
Status:
UNKNOWN
Last Update Posted:
2017-11-01
First Post:
2017-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28-day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS']}, 'descriptionModule': {'briefSummary': 'To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.', 'detailedDescription': '70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h\n2. Patients age between 18 years old and 80 years.\n\nExclusion Criteria：\n\n1. Pregnant women,\n2. Patients with malignant tumor,\n3. Immunosuppression or immunocompromised patients.'}, 'identificationModule': {'nctId': 'NCT03296761', 'briefTitle': 'Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury', 'orgStudyIdInfo': {'id': '2017ZDSYLL081-P01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESM-1<5ng/ml'}, {'label': 'ESM-1≥5ng/ml'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanyuan YU', 'role': 'CONTACT', 'email': '220153911@seu.edu.cn', 'phone': '15651680953'}], 'facility': 'Nanjing Zhongda Hospital, School of Medicine, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yuanyuan YU', 'role': 'CONTACT', 'email': '220153911@seu.edu.cn', 'phone': '15651680953'}, {'name': 'Haibo qiu', 'role': 'CONTACT', 'email': 'haiboq2000@163.com', 'phone': '+862583262550'}], 'overallOfficials': [{'name': 'Haibo qiu', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhong-Da Hospital, School of Medicine, Southeast University,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jingyuan,Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'chief doctor', 'investigatorFullName': 'Jingyuan,Xu', 'investigatorAffiliation': 'Southeast University, China'}}}}