Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT06733961
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2024-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCUBE-1 and VAP-1 Levels on Diagnosis Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'To study SCUBE-1 and VAP-1, 5 cc of blood was taken from each patient and healthy volunteer.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic ability of SCUBE-1 and VAP-1 in pulmonary embolism', 'timeFrame': '6 month', 'description': 'Serum SCUBE-1 and serum VAP-1 levels of the Patient and Control groups will be measured in serum mg/dL with 5 mL of blood taken from the peripheral veins.'}], 'secondaryOutcomes': [{'measure': 'Difference between clinical probability scores and serum SCUBE-1 and VAP-1 levels.', 'timeFrame': '6 month', 'description': "The clinical probability scores of the patient group will be grouped as 'low, medium, high' and 'APT likely, APT unlikely'. Serum SCUBE-1 and serum VAP-1 levels measured in the patient group will be measured in the subgroups of clinical probability scores."}, {'measure': 'difference between early mortality risk and serum SCUBE-1 and VAP-1 levels.', 'timeFrame': '28 days', 'description': "For the patient group, 'low, medium-low, medium-high, high' risk groups will be determined for the 28-day early mortality risk. Serum SCUBE-1 and serum VAP-1 levels will be measured for these subgroups."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SCUBE-1', 'VAP-1', 'Pulmonary Embolism'], 'conditions': ['Pulmonary Embolism Acute']}, 'referencesModule': {'references': [{'pmid': '27803754', 'type': 'BACKGROUND', 'citation': 'Dirican N, Duman A, Saglam G, Arslan A, Ozturk O, Atalay S, Bircan A, Akkaya A, Cakir M. The diagnostic significance of signal peptide-complement C1r/C1s, Uegf, and Bmp1-epidermal growth factor domain-containing protein-1 levels in pulmonary embolism. Ann Thorac Med. 2016 Oct-Dec;11(4):277-282. doi: 10.4103/1817-1737.191876.'}, {'pmid': '26202675', 'type': 'BACKGROUND', 'citation': 'Turkmen S, Sahin A, Gunaydin M, Sahin S, Mentese A, Turedi S, Karahan SC, Ozsu S, Gunduz A. The value of signal peptide-CUB-EGF domain-containing protein-1 (SCUBE1) in the diagnosis of pulmonary embolism: a preliminary study. Acad Emerg Med. 2015 Aug;22(8):922-6. doi: 10.1111/acem.12721. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'Acute pulmonary thromboembolism is a life-threatening disease. Clinical suspicion is essential for diagnosis because of lack of a specific finding for diagnosis of PTE. The aim of this study is to investigate the relationship between the diagnosis and prognosis of alternative biomarkers such as SCUBE-1 and VAP-1 in the diagnosis of clinically suspected acute PTE.\n\nPatients who were admitted to the Emergency Department and diagnosed as acute PTE were included in the study. Patients with acute ischemic disease, liver failure, renal failure, pregnancy, active malignancy and/or history of known PTE were excluded from the study. A control group was formed from healthy volunteers at similar age and sex. SCUBE-1 and VAP-1 levels were studied from serum samples taken from the patient and control groups. Data were analyzed using by IBM SPSS V23.', 'detailedDescription': 'The definitive diagnosis of APT is made by ventilation/perfusion (V/Q) scintigraphy and thorax computed tomography angiography (CTA). There is no specific examination as a laboratory parameter. A definitive diagnosis cannot be made with d-Dimer, which is the most frequently used laboratory test today; it is used to exclude the diagnosis of APT.\n\nThe non-specificity of the clinical picture, the fact that the diagnosis depends on the experience of the physician and the necessity of exposure to radiation and contrast material for the definitive diagnosis has revealed the necessity of searching for alternative ways for the diagnosis of APT. "Signal peptide CUB-EGF domain-containing protein-1" (SCUBE-1) is a biomarker released during platelet aggregation, and "Vascular adhesion protein-1" (VAP-1) is a biomarker released from endothelium, and these biomarkers show promise for the diagnosis of APT.\n\nDetermination of serum SCUBE-1 and serum VAP-1 levels 5 mL blood taken from the peripheral veins of the patients was placed in a biochemistry tube and centrifuged at 3000 g. After centrifugation, the serum part of the blood was separated and taken into an eppendorf tube and stored in an ultra-deep freezer at minus 80°C until the study day. Before starting the study, the ELISA kits kept at 2-8°C and the samples kept in an ultra-deep freezer at minus 80°C were brought to room temperature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients who applied to the emergency department of Samsun Ondokuz Mayis Universtiy between 01.01.2019 and 30.06.2019 and were diagnosed with acute pulmonary thromboembolism (APT) by contrast-enhanced thorax computed tomography were included in the study. A group of healthy volunteers with similar gender, age and exclusion criteria was formed with the patients with APT included in the study. Demographic data, clinical probability scores (Wells' criteria, revised Geneva score), simplified Pulmonary Embolism Severity Index (sPESI) and early mortality risk score (in 30 days) of the patients were recorded.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being older than 18 years of age\n* presenting to the emergency department,\n* diagnosed with acute PTE by contrast-enhanced computed tomography angiography\n\nExclusion Criteria:\n\n* having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.'}, 'identificationModule': {'nctId': 'NCT06733961', 'briefTitle': 'SCUBE-1 and VAP-1 Levels on Diagnosis Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Giresun University'}, 'officialTitle': 'Investigation of the Relationship of SCUBE-1 and VAP-1 Levels on Diagnosis, Prognosis and Clinical Results in Patients with Pulmonary Thromboembolism Diagnosis in Emergency Department', 'orgStudyIdInfo': {'id': 'OMÜ KAEK 2019/26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient group', 'description': 'It consists of patients diagnosed with Pulmonary Thromboembolism who meet the inclusion and exclusion criteria.', 'interventionNames': ['Diagnostic Test: SCUBE-1 and VAP-1']}, {'label': 'Control group', 'description': 'It was composed of healthy volunteers of similar age and gender who did not have any acute complaints.', 'interventionNames': ['Diagnostic Test: SCUBE-1 and VAP-1']}], 'interventions': [{'name': 'SCUBE-1 and VAP-1', 'type': 'DIAGNOSTIC_TEST', 'description': 'There is no other study comparing these biomarkers with healthy volunteers in the diagnosis of pulmonary embolism.', 'armGroupLabels': ['Control group', 'Patient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Hizir U. Akdemir, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giresun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'İskender Aksoy', 'investigatorAffiliation': 'Giresun University'}}}}