Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-06 @ 3:31 AM
Study NCT ID:
NCT03830060
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-02', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean difference of cortisol before and after treatment', 'timeFrame': '72 hours', 'description': 'Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marker of inflammation', 'high-sensitivity CRP', 'Antinuclear antibodies', 'Cortisol'], 'conditions': ['Acute Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '17625291', 'type': 'BACKGROUND', 'citation': 'Zhang XP, Zhang L, Wang Y, Cheng QH, Wang JM, Cai W, Shen HP, Cai J. Study of the protective effects of dexamethasone on multiple organ injury in rats with severe acute pancreatitis. JOP. 2007 Jul 9;8(4):400-12.'}, {'pmid': '12483249', 'type': 'BACKGROUND', 'citation': 'Imamura T, Tanaka S, Yoshida H, Kitamura K, Ikegami A, Takahashi A, Niikawa J, Mitamura K. Significance of measurement of high-sensitivity C-reactive protein in acute pancreatitis. J Gastroenterol. 2002;37(11):935-8. doi: 10.1007/s005350200157.'}, {'pmid': '29215538', 'type': 'BACKGROUND', 'citation': 'Nebiker CA, Staubli S, Schafer J, Bingisser R, Christ-Crain M, Dell-Kuster S, Mueller C, Scamardi K, Viehl CT, Kolleth D, von Holzen U, Oertli D, Rosenthal R. Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis. Pancreas. 2018 Jan;47(1):55-64. doi: 10.1097/MPA.0000000000000962.'}, {'pmid': '22844291', 'type': 'BACKGROUND', 'citation': 'Smyk DS, Rigopoulou EI, Koutsoumpas AL, Kriese S, Burroughs AK, Bogdanos DP. Autoantibodies in autoimmune pancreatitis. Int J Rheumatol. 2012;2012:940831. doi: 10.1155/2012/940831. Epub 2012 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis (AP) is a potentially life-threatening disease with varying severity of presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although alcohol abuse is the more common cause in men and gallstones is the more common cause in women.', 'detailedDescription': 'Severe acute pancreatitis is one of the most common acute abdomens in clinical practice. Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical study spot and one of the toughest medical problems. Markers of inflammation, such as high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may be useful in identifying patients with severe acute pancreatitis in the early phase after onset.\n\nAntinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured. Although the association between serum levels of some inflammatory marker and acute pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity of acute pancreatic lesions have not evaluated yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute pancreatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abdominal pain consistent with AP\n* serum amylase activity at least 3 times greater than the upper limit of normal\n* Patients of age 18 years or more who are willing to participate in the study and give their consent for same.\n\nExclusion Criteria:\n\n* Patients with severe liver disease, pulmonary embolus, sepsis, and renal failure were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03830060', 'briefTitle': 'Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Diagnostic and Prognostic Evaluation of Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'Pancreatitis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I:', 'description': 'Fifty AP patients on admission', 'interventionNames': ['Diagnostic Test: Measurement of cortisol']}, {'label': 'Group II:', 'description': 'The previous AP patients after 72 hours', 'interventionNames': ['Diagnostic Test: Measurement of cortisol']}], 'interventions': [{'name': 'Measurement of cortisol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP', 'armGroupLabels': ['Group I:', 'Group II:']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'reham elmahdy', 'role': 'CONTACT', 'email': 'reham.elmahdy@aun.edu.eg', 'phone': '+201002714637'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reham I El-mahdy', 'investigatorAffiliation': 'Assiut University'}}}}