Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
Study NCT ID:
NCT06809868
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-01-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Transposable Elements in Septic Immune Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D060085', 'term': 'Coinfection'}], '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'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012313', 'term': 'RNA'}, {'id': 'D017422', 'term': 'Sequence Analysis, DNA'}], 'ancestors': [{'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma, RNA, and DNA from patients with sepsis will be retained and analyzed as part of this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune Aging', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Mortality (30-day)', 'timeFrame': '30 days'}, {'measure': 'Secondary Infection', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Transposable Elements', 'Immune Aging', 'Mortality', 'Secondary Infections', 'Critical Care Medicine (ICU)'], 'conditions': ['Sepsis', 'Sepsis and Septic Shock', 'Sepsis With Multiple Organ Dysfunction (MOD)', 'Sepsis With Acute Organ Dysfunction', 'Sepsis, Severe', 'Sepsis at Intensive Care Unit', 'Sepsis, Severe Sepsis and Septic Shock', 'Sepsis, Septic Shock']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:\n\n1. Do transposable elements prematurely age the immune systems of patients with sepsis?\n2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?\n3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?\n\nParticipants will have blood drawn from them but will not be subjected to additional interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adult patients admitted to the intensive care unit with sepsis with a SOFA score of at least 2. Sepsis is defined by the Sepsis 3 Criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Admitted to ICU with sepsis (Sepsis 3 Criteria)\n* SOFA score of at least 2 at time of enrollment\n\nExclusion Criteria:\n\n* Patients on organ transplantation immunosuppression\n* Patients with preexisting leukopenia\n* Cancer patients receiving CAR-T therapy\n* Patients who are under 18 years of age or otherwise deemed pediatric\n* Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)\n* Patients with a chronic hemoglobin below 7.0\n* Patients who, prior to their ICU admission, are blood transfusion dependent'}, 'identificationModule': {'nctId': 'NCT06809868', 'acronym': 'SITE', 'briefTitle': 'Role of Transposable Elements in Septic Immune Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Role of Transposable Elements in Septic Immune Aging', 'orgStudyIdInfo': {'id': '23-39420'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Sepsis', 'description': 'Adult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria.', 'interventionNames': ['Genetic: RNA and DNA Sequencing']}, {'label': 'Healthy Individual Controls', 'description': 'Healthy individuals not admitted to the hospital.', 'interventionNames': ['Genetic: RNA and DNA Sequencing']}], 'interventions': [{'name': 'RNA and DNA Sequencing', 'type': 'GENETIC', 'description': 'DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.', 'armGroupLabels': ['Healthy Individual Controls', 'Patients with Sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexendar R Perez, M.D., Ph.D', 'role': 'CONTACT', 'email': 'Alexendar.Perez@ucsf.edu', 'phone': '415-476-1000'}, {'name': 'Matthieu Legrand, M.D., Ph.D', 'role': 'CONTACT', 'email': 'matthieu.legrand@ucsf.edu', 'phone': '415-476-1000'}, {'name': 'Alexendar R Perez, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Judith Hellman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthieu Legrand, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elizabeth Whitlock, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Orestes Mavrothalassitis, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joana Vidigal, Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Alexendar R Perez, M.D., Ph.D', 'role': 'CONTACT', 'email': 'Alexendar.Perez@ucsf.edu', 'phone': '415-476-1000'}, {'name': 'Matthieu Legrand, M.D., Ph.D', 'role': 'CONTACT', 'email': 'matthieu.legrand@ucsf.edu', 'phone': '415-476-1000'}], 'overallOfficials': [{'name': 'Alexendar R Perez, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Judith Hellman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Matthieu Legrand, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}