Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:12 AM
Study NCT ID:
NCT05093660
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2021-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of LGR1 protein in blood', 'timeFrame': '72 hours', 'description': 'Levels of LGR1 protein in blood and saliva as measured by ELISA test'}, {'measure': 'Level of LGR1 protein saliva', 'timeFrame': '72 hours', 'description': 'Levels of LGR1 protein in saliva as measured by ELISA test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis Acute']}, 'descriptionModule': {'briefSummary': 'Acute appendicitis is a common and potentially serious medical condition which can be difficult to diagnose, especially in pediatric patients. To help recognize patients with acute appendicitis, number of laboratory and radiological test are used. Previous research has shown that Circulating Human Leucine-rich α-2-glycoprotein (LGR1) in the blood can be elevated in pediatric patients with acute appendicitis. The aim of this research is to analyse whether LGR1 levels in saliva can be used as a less invasive diagnostic method in pediatric patients with suspected acute appendicitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with age from 5 do 17 with acute abdominal pain\n* children with clinical signs of appendicitis\n\nExclusion Criteria:\n\n* previous diagnosis of chronic and/or malignant disease\n* children which had previous abdominal surgery\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT05093660', 'briefTitle': 'Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'KBC Split'}, 'officialTitle': 'Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein Analysed From Blood and Saliva in Children With Acute Appendicitis', 'orgStudyIdInfo': {'id': '2181-147/01/06/M.S.-20-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute appendicitis', 'description': 'Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.', 'interventionNames': ['Diagnostic Test: Blood specimen collection', 'Diagnostic Test: Saliva specimen collection']}, {'label': 'Patients without acute appendicitis', 'description': 'Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.', 'interventionNames': ['Diagnostic Test: Blood specimen collection', 'Diagnostic Test: Saliva specimen collection']}], 'interventions': [{'name': 'Blood specimen collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood specimen collection for analysis of CRP (C-reactive protein), WBC (White blood cells) and LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels', 'armGroupLabels': ['Patients with acute appendicitis', 'Patients without acute appendicitis']}, {'name': 'Saliva specimen collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels', 'armGroupLabels': ['Patients with acute appendicitis', 'Patients without acute appendicitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Split', 'state': 'Split-Dalmatia County', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Zenon Pogorelić, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University Hospital Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'centralContacts': [{'name': 'Goran Tintor, MD', 'role': 'CONTACT', 'email': 'gogitintor@gmail.com', 'phone': '+38521557111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KBC Split', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Plastic surgery resident', 'investigatorFullName': 'Goran Tintor', 'investigatorAffiliation': 'KBC Split'}}}}