Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05703802
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2023-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio between native and truncated procalcitonin during different conditions of hyperprocalcitoninemia', 'timeFrame': 'Blood withdrawal takes approximately 5 minutes per patient', 'description': 'Measurement performed by using ELISA-assay.'}], 'secondaryOutcomes': [{'measure': 'DPP-4-activity', 'timeFrame': 'Blood withdrawal takes approximately 5 minutes per patient', 'description': 'Measurement performed by using a commercial DPP4-ELISA-kit.'}, {'measure': 'Proinflammatory cytokines', 'timeFrame': 'Blood withdrawal takes approximately 5 minutes per patient', 'description': 'Measurement performed by using a commercial multiplex immunoassay kit.'}, {'measure': 'Immun cell surface-antigens', 'timeFrame': 'Blood withdrawal takes approximately 5 minutes per patient', 'description': 'Measurement performed by using fluorescence-acivated cell sorting (FACS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Pre-Eclampsia', 'Granulomatosis With Polyangiitis', 'Microscopic Polyangiitis', 'Adiposity', 'SIRS', 'Procalcitonin']}, 'referencesModule': {'references': [{'pmid': '10648832', 'type': 'BACKGROUND', 'citation': 'Wrenger S, Kahne T, Bohuon C, Weglohner W, Ansorge S, Reinhold D. Amino-terminal truncation of procalcitonin, a marker for systemic bacterial infections, by dipeptidyl peptidase IV (DP IV). FEBS Lett. 2000 Jan 21;466(1):155-9. doi: 10.1016/s0014-5793(99)01779-2.'}, {'pmid': '35699655', 'type': 'BACKGROUND', 'citation': "Brabenec L, Muller M, Hellenthal KEM, Karsten OS, Pryvalov H, Otto M, Holthenrich A, Matos ALL, Weiss R, Kintrup S, Hessler M, Dell'Aquila A, Thomas K, Nass J, Margraf A, Nottebaum AF, Rossaint J, Zarbock A, Vestweber D, Gerke V, Wagner NM. Targeting Procalcitonin Protects Vascular Barrier Integrity. Am J Respir Crit Care Med. 2022 Aug 15;206(4):488-500. doi: 10.1164/rccm.202201-0054OC."}, {'pmid': '11786196', 'type': 'RESULT', 'citation': 'Weglohner W, Struck J, Fischer-Schulz C, Morgenthaler NG, Otto A, Bohuon C, Bergmann A. Isolation and characterization of serum procalcitonin from patients with sepsis. Peptides. 2001 Dec;22(12):2099-103. doi: 10.1016/s0196-9781(01)00541-1.'}, {'pmid': '39636188', 'type': 'DERIVED', 'citation': 'Kintrup S, Brabenec L, Zurek-Leffers FM, Hellenthal KEM, Cyran L, Meybohm P, Gerke V, Wagner NM. Detection and Evaluation of Procalcitonin Variants As Diagnostic Tools in Systemic Inflammation. Anesth Analg. 2025 May 1;140(5):1073-1082. doi: 10.1213/ANE.0000000000007170.'}]}, 'descriptionModule': {'briefSummary': 'Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. However, it is unknown if this applies also in humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.', 'detailedDescription': 'Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids.\n\nWithin their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice: They observed that binding of truncated procalcitonin to the CRLR/RAMP1-receptor on vascular endothelium lead to phosphorylation and destruction of VE-cadherin, an essential part of adherens junctions. Consequently, paracellular leakage of proteins and fluid from blood vessels developed.\n\nIt is unknown if these effects also apply to humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data. Futhermore, they want to examine if the procalcitonin-variants have influence on cytokine levels and surface antigens on immune cells by performing multiplex immunoassays and FACS-analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the University Hospital Münster who suffer from different diseases which are accompanied by hyperprocalcitoninemia.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Patients with diagnosis...\n* Sepsis or,\n* SIRS after cardiothoracic surgery or,\n* adipositas or,\n* granulomatosis with polyangiitis/microscopic polyangiitis or,\n* pre-eclampsia\n* healthy control subjects\n* written informed consent\n\nExclusion Criteria:\n\n* participation in an interventional study trial within the last 3 months\n* relationship to study investigator'}, 'identificationModule': {'nctId': 'NCT05703802', 'briefTitle': 'Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Establishment of an Enzyme-linked Immunosorbent Assay for the Recognition of Procalcitonin Variants and Characterization of Procalcitonin Variants in Patients With Hyperprocalcitonemia.', 'orgStudyIdInfo': {'id': '10-AnIt-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}, {'label': 'SIRS', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}, {'label': 'Adiposity', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}, {'label': 'Granulomatosis with polyangiitis / microscopic polyangiitis', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}, {'label': 'Pre-eclampsia', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}, {'label': 'Healthy controls', 'description': 'Withdrawal of 3 blood collection tubes for ELISA-measurements at a single time during hyperprocalcitoninemia.', 'interventionNames': ['Diagnostic Test: Procalcitonin-variants ELISA-Assay']}], 'interventions': [{'name': 'Procalcitonin-variants ELISA-Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational study measuring procalcitonin-variants in different patient collectives by obtaining 3 blood collection tubes per patient.', 'armGroupLabels': ['Adiposity', 'Granulomatosis with polyangiitis / microscopic polyangiitis', 'Healthy controls', 'Pre-eclampsia', 'SIRS', 'Sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48147', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sebastian Kintrup', 'investigatorAffiliation': 'University Hospital Muenster'}}}}