Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04252651
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2020-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine Response that develops into complications', 'timeFrame': 'up to one year', 'description': 'The number of burn and TENS patients that develop subsequent medical complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Response', 'Multi Organ Failure', 'Nosocomial Infection', 'Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples size will be patients from the burn ICU.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* is ≥18 years of age\n* has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days\n* the subject or their legally authorized representative is able to provide informed consent\n* has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)\n\nExclusion Criteria:\n\n* is moribund, or in the opinion of the investigator is not expected to survive\n* has sustained an electrical burn'}, 'identificationModule': {'nctId': 'NCT04252651', 'briefTitle': 'Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Joseph M. Still Research Foundation, Inc.'}, 'officialTitle': 'Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients', 'orgStudyIdInfo': {'id': 'JMSRF-CYT-P04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood Draw', 'description': 'This study will involve blood draws to test for specific cytokines', 'interventionNames': ['Other: Blood Draw']}], 'interventions': [{'name': 'Blood Draw', 'type': 'OTHER', 'description': 'This study will involve blood draws to test for specific cytokines', 'armGroupLabels': ['Blood Draw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joan Wilson', 'role': 'CONTACT', 'email': 'joan.wilson@jmsresearchfoundation.org', 'phone': '706-364-2966'}, {'name': 'Michael Quinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marcos Aranda, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Elseth, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Constance Joel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Balakrishna Prasad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Joseph M. Still Burn Center at Doctors Hospital', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Joan Wilson', 'role': 'CONTACT', 'email': 'joan.wilson@jmsresearchfoundation.org', 'phone': '7063642966'}], 'overallOfficials': [{'name': 'Michael Quinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joseph M. Still Research Foundation, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Study results will be analyzed, and study data presented at an appropriate related Congress meeting. Journal publication in a related peer-reviewed journal would be expected after presentation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph M. Still Research Foundation, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}