Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT03929159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlating MicroRNA Changes With Sepsis Outcomes
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cellular and viral micro ribonucleic acids (miRNAs)', 'timeFrame': 'Baseline up to day 1', 'description': 'For each of the cellular and viral miRNAs, samples from patients with sepsis versus (vs.) patients with systemic inflammatory response syndrome (SIRS) without sepsis vs. patients presenting for pre-op evaluation (reference group without SIRS or sepsis) will be compared by one-way analysis of variance. Will compare the miRNA expression intergroup differences.'}, {'measure': '7-day mortality rate', 'timeFrame': 'Baseline up to day 7', 'description': 'Will be correlated with miRNA changes. Will compare the changes of the miRNAs from baseline to day 1 between the patients who were still alive 7 days after diagnosis of sepsis and those who died within 7 days of sepsis diagnosis.'}], 'secondaryOutcomes': [{'measure': 'T and B cells immune phenotypes', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septicemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how changes in microRNAs may correlate with sepsis outcomes. Sepsis is a type of severe infection of the blood stream, and its diagnosis may be obscured by many other conditions such as surgery, trauma, and cancer. MicroRNAs are biomarkers found in the blood and tissue. Blood samples may help correlate changes in microRNA expression to patient reactions to a sepsis infection.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of sepsis.\n\nSECONDARY OBJECTIVES:\n\nI. To distinguish systemic inflammatory response syndrome (SIRS) without infection from sepsis and septic shock.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nGROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.\n\nGROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients electively scheduled for surgical operation requiring anesthesia and hospitalization of longer than 1 day, or patients with high clinical suspicion of sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Electively scheduled for surgical operation that require general anesthesia and expected duration of hospitalization of longer than one day (for patients in Perioperative Evaluation \\& Management \\[POEM\\]) or high clinical suspicion of sepsis by the emergency physician (for patients in emergency center)\n* Ability to give informed consent. If the patient is incapacitated and unable to give informed consent, the next-of-kin or a person who has the power of attorney must be present for informed consent.\n* For patients in the emergency center only, two or more of the following SIRS criteria:\n\n * Leukocytes \\> 12,000/mm\\^3 or \\< 4,000/mm\\^3 or \\> 10% immature (band) forms, provided that no filgrastim or pegfilgrastim was administered within 30 days and no leukemia\n * Heart rate \\> 90 beats/minute (min)\n * Respiratory rate \\> 20 breaths/min or partial pressure of carbon dioxide (CO2) \\< 32 mmHg\n * Oral temperature \\> 38 degrees Celsius (C) or \\< 36 degrees C or axillary temperature \\> 37 degrees C or \\< 35 degrees C\n\nExclusion Criteria:\n\n* Inability to give informed consent or a person who has power of attorney for medical decision is not available\n* Being moribund (for patients in emergency center) or cancellation of surgery (for patients in POEM)\n* Active "Do Not Resuscitate" or "Do Not Intubate" order'}, 'identificationModule': {'nctId': 'NCT03929159', 'briefTitle': 'Correlating MicroRNA Changes With Sepsis Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Profile of miRNA Changes in Sepsis and Surgical Trauma', 'orgStudyIdInfo': {'id': '2018-0757'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00833', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0757', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'R01GM122775', 'link': 'https://reporter.nih.gov/quickSearch/R01GM122775', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A (biospecimen collection)', 'description': 'Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.', 'interventionNames': ['Procedure: Biospecimen Collection']}, {'label': 'Group B (biospecimen collection)', 'description': 'Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.', 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo blood biospecimen collection', 'armGroupLabels': ['Group A (biospecimen collection)', 'Group B (biospecimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sai-Ching J Yeung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}