Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 5:57 AM
Study NCT ID:
NCT05568433
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2022-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, cystic fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-04', 'studyFirstSubmitDate': '2022-09-25', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl'}], 'secondaryOutcomes': [{'measure': 'The Correlation between cyst fluid concentration and serum level of the specific biomarkers', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'coefficient of correlation between the two values'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic cyst', 'EUS-FNA', 'intracystic fluid'], 'conditions': ['Pancreatic Cyst']}, 'referencesModule': {'references': [{'pmid': '33456526', 'type': 'BACKGROUND', 'citation': 'Tan JH, Chin W, Shaikh AL, Zheng S. Pancreatic pseudocyst: Dilemma of its recent management (Review). Exp Ther Med. 2021 Feb;21(2):159. doi: 10.3892/etm.2020.9590. Epub 2020 Dec 18.'}, {'pmid': '24385209', 'type': 'BACKGROUND', 'citation': 'Del Chiaro M, Segersvard R, Pozzi Mucelli R, Rangelova E, Kartalis N, Ansorge C, Arnelo U, Blomberg J, Lohr M, Verbeke C. Comparison of preoperative conference-based diagnosis with histology of cystic tumors of the pancreas. Ann Surg Oncol. 2014 May;21(5):1539-44. doi: 10.1245/s10434-013-3465-9. Epub 2014 Jan 3.'}, {'pmid': '31527862', 'type': 'BACKGROUND', 'citation': 'van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16.'}, {'pmid': '22513004', 'type': 'BACKGROUND', 'citation': 'Chakraborty S, Kaur S, Guha S, Batra SK. The multifaceted roles of neutrophil gelatinase associated lipocalin (NGAL) in inflammation and cancer. Biochim Biophys Acta. 2012 Aug;1826(1):129-69. doi: 10.1016/j.bbcan.2012.03.008. Epub 2012 Mar 31.'}, {'pmid': '22962216', 'type': 'BACKGROUND', 'citation': 'Clerico A, Galli C, Fortunato A, Ronco C. Neutrophil gelatinase-associated lipocalin (NGAL) as biomarker of acute kidney injury: a review of the laboratory characteristics and clinical evidences. Clin Chem Lab Med. 2012 Feb 15;50(9):1505-17. doi: 10.1515/cclm-2011-0814.'}, {'pmid': '18809975', 'type': 'BACKGROUND', 'citation': 'Devarajan P. Neutrophil gelatinase-associated lipocalin--an emerging troponin for kidney injury. Nephrol Dial Transplant. 2008 Dec;23(12):3737-43. doi: 10.1093/ndt/gfn531. Epub 2008 Sep 22. No abstract available.'}, {'pmid': '33122517', 'type': 'BACKGROUND', 'citation': 'Bhatia R, Muniyan S, Thompson CM, Kaur S, Jain M, Singh RK, Dhaliwal A, Cox JL, Akira S, Singh S, Batra SK, Kumar S. Neutrophil Gelatinase-Associated Lipocalin Protects Acinar Cells From Cerulein-Induced Damage During Acute Pancreatitis. Pancreas. 2020 Nov/Dec;49(10):1297-1306. doi: 10.1097/MPA.0000000000001690.'}, {'pmid': '20179686', 'type': 'BACKGROUND', 'citation': 'Chakraborty S, Kaur S, Muddana V, Sharma N, Wittel UA, Papachristou GI, Whitcomb D, Brand RE, Batra SK. Elevated serum neutrophil gelatinase-associated lipocalin is an early predictor of severity and outcome in acute pancreatitis. Am J Gastroenterol. 2010 Sep;105(9):2050-9. doi: 10.1038/ajg.2010.23. Epub 2010 Feb 23.'}, {'pmid': '32575507', 'type': 'BACKGROUND', 'citation': 'Santiago-Sanchez GS, Pita-Grisanti V, Quinones-Diaz B, Gumpper K, Cruz-Monserrate Z, Vivas-Mejia PE. Biological Functions and Therapeutic Potential of Lipocalin 2 in Cancer. Int J Mol Sci. 2020 Jun 19;21(12):4365. doi: 10.3390/ijms21124365.'}, {'pmid': '23146921', 'type': 'BACKGROUND', 'citation': 'Kaur S, Baine MJ, Guha S, Ochi N, Chakraborty S, Mallya K, Thomas C, Crook J, Wallace MB, Woodward TA, Jain M, Singh S, Sasson AR, Skinner V, Raimondo M, Batra SK. Neutrophil gelatinase-associated lipocalin, macrophage inhibitory cytokine 1, and carbohydrate antigen 19-9 in pancreatic juice: pathobiologic implications in diagnosing benign and malignant disease of the pancreas. Pancreas. 2013 Apr;42(3):494-501. doi: 10.1097/MPA.0b013e31826a8597.'}]}, 'descriptionModule': {'briefSummary': 'Due to the advances made in the field of the imaging techniques and their common use, pancreatic cysts are more and more incidentally found.\n\nPancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is no clinical history of acute or chronic pancreatitis. Pancreatic cystic neoplasms on the other hand are rare, but are difficult to diagnose accurately.\n\nNeutrophil gelatinase-associated lipocalin (NGAL) , interleukin 1 Beta (IL1beta) and High Mobility Group AT-Hook 2 (HmgA2) are molecules implicated in the process of inflammation and tumour development. The diagnostic value of their concentration in pancreatic cysts is not established yet.\n\nStudy aim to asses the significance of NGAL,IL1Beta and HMGA2 concentration in cystic fluid obtained by endoscopic ultrasound (EUS) with EUS-guided fine-needle aspiration (EUS-FNA) and serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients aged 18-90 years diagnosed with an unclear specific diagnosis of pancreatic cysts \\>15mm on Computer tomography scan (CT) or Magnetic resonance imaging (MRI) and patients with pseudocysts with indication for drainage , admitted to our hospital (the Regional Institute of Gastroenterology and Hepatology in Cluj-Napoca, Romania)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-90 years with an unclear specific diagnosis of pancreatic cysts\n* pancreatic cyst \\>15mm on CT or MRI\n* patients with pseudocysts with indication for drainage\n\nExclusion Criteria:\n\n* refusal to participate\n* platelet level \\< 50000/mm3 and International normalized ratio (INR \\>1.5)\n* duodenal stenosis\n* severe chronic pancreatitis\n* history of pancreatic cancer or major upper abdominal surgery\n* congestive heart failure\n* the liquid sample \\< 1ml;'}, 'identificationModule': {'nctId': 'NCT05568433', 'briefTitle': 'New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions', 'orgStudyIdInfo': {'id': '202042018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic ultrasound fine needle aspiration (EUS-FNA)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ELISA measurements of cystic fluid'], 'description': 'Patients with pancreatic cysts who underwent endoscopic ultrasound and endoscopic fine needle aspiration for diagnostic and therapeutic purpose. A sample of the cyst fluid and frozen serum was collected from the patients and stored at minus 80 degrees.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'overallOfficials': [{'name': 'Andrada Seicean, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Olar Miruna-Patricia', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}