Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 6:23 AM
Study NCT ID:
NCT05094960
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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_WITH_DNA', 'description': 'Blood test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prolong LOS-length of stay', 'timeFrame': '> 18 hours after the surgery', 'description': 'intensive care unit length of stay'}, {'measure': 'Mortality', 'timeFrame': 'short term - 30day; long term > 1year', 'description': 'Mortality'}], 'secondaryOutcomes': [{'measure': 'Neutrophil-NETosis', 'timeFrame': '2 hours after the surgery', 'description': 'Neutrophil extracellular traps (NETs) released from activated neutrophils that undergo NETosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cfDNA-Circulating cell-free DNA', 'CPB-cardiopulmonary bypass', 'SIRS-systemic inflammatory response syndrome'], 'conditions': ['Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes']}, 'descriptionModule': {'briefSummary': 'To characterize the changes in circulating cell-free DNA (cfDNA) levels during cardiopulmonary bypass (CPB) and to access their association with outcomes compared to standard scores.', 'detailedDescription': 'In a prospective study, the investigators enrolled seventy-one consecutive patients undergoing non-emergent coronary artery bypass grafting. Blood was drawn at baseline, after 20 and 40 minutes on CPB, after cross-clamp removal, and 30 minutes after chest closure. cfDNA was measured in sera by fluorescent method.\n\nThe investigators hypothesize that cfDNA measured by will reflect the magnitude of inflammation induced by CPB. Thus, these measurements could serve for the real-time prognosis of patients undergoing cardiac surgery. The investigators correlate cFDNA to laboratories and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult (\\>18yo), undergoing non-emergent first-time CABG.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective coronary artery bypass grafting surgery\n\nExclusion Criteria:\n\n* Age \\< 18\n* Non elective surgery\n* other than CABG surgery\n* Redo CABG'}, 'identificationModule': {'nctId': 'NCT05094960', 'briefTitle': 'Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Development of a Fast and Sensitive Method for Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage Following Trauma', 'orgStudyIdInfo': {'id': 'SOR4636CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': '5 blood samples for each patient during CABG (coronary artery bypass grafting) surgery pre/on/post cardiopulmonary bypass machine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}