Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 4:56 PM
Study NCT ID:
NCT01882569
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells', 'timeFrame': 'Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge', 'description': 'This is an exploratory study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Trauma']}, 'descriptionModule': {'briefSummary': 'Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Generally healthy patients undergoing back surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18 - 90\n2. Men and women\n3. Undergo back surgery\n\nExclusion Criteria:\n\n1. Any systemic disease that might compromise the immune system (e.g. lupus)\n2. Current diagnosis of cancer\n3. Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.\n4. Unwilling to sign informed consent'}, 'identificationModule': {'nctId': 'NCT01882569', 'briefTitle': 'Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis', 'orgStudyIdInfo': {'id': '24014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Back surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Martin S Angst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University SOM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin Angst', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia', 'investigatorFullName': 'Martin Angst', 'investigatorAffiliation': 'Stanford University'}}}}