Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-07 @ 6:21 AM
Study NCT ID:
NCT07008092
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine 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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PGE-M', 'timeFrame': '72 hours', 'description': 'Levels of prostaglandin E urinary metabolite as measured with ELISA test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute appendicitis', 'PGE-M', 'Prostaglandin-E urinary metabolite'], 'conditions': ['Acute Appendicitis', 'Acute Appendicitis With Rupture', 'Abdominal Pain (AP)']}, 'descriptionModule': {'briefSummary': 'Diagnosing acute appendicitis in children remains a clinical challenge, with delayed or incorrect diagnosis potentially leading to serious complications or unnecessary surgery. Prostaglandin E urinary metabolites (PGE-M) have been found elevated in various inflammatory conditions, but their diagnostic value in pediatric appendicitis is not well established. This study aims to assess the potential of PGE-M as a biomarker for acute appendicitis in children.\n\nThe study will be conducted over 12 months and will include 100 children aged 5 to 17 years presenting with acute abdominal pain. In addition to routine laboratory tests, urinary PGE-M levels will be analyzed. The study involves minimal risk to participants', 'detailedDescription': 'The diagnosis of acute appendicitis in children remains a challenge, even for experienced clinicians. Failure to recognize this acute condition may result in perforation and subsequent peritonitis, whereas misdiagnosis can lead to unnecessary (negative) appendectomies. Elevated levels of prostaglandin E urinary metabolites (PGE-M) have been observed in other inflammatory conditions such as inflammatory bowel disease, acute mesenteric ischemia, and necrotizing enterocolitis.\n\nThe aim of this study is to determine whether PGE-M levels are elevated in children with acute appendicitis and whether this biomarker could be used in the diagnosis of acute appendicitis.\n\nThe planned duration of the study is 12 months, with a projected sample size of 100 participants.\n\nInclusion criteria: Children aged 5 to 17 years presenting with acute abdominal pain and signs and symptoms suggestive of acute appendicitis, without significant comorbidities.\n\nExclusion criteria: Children outside the specified age range, those with a previously diagnosed chronic or malignant disease, a history of abdominal surgery, or pregnancy.\n\nFor each child included in the study, demographic data, clinical characteristics, laboratory and diagnostic test results, intraoperative findings, and discharge diagnoses will be recorded. Since the child is already indicated for surgery or hospital admission regardless of study participation, there are no significant risks associated with participation in this study-apart from potential, but rare, complications related to peripheral venous blood sampling (e.g., hematoma or discomfort).\n\nFor the purposes of the study, a peripheral venous blood sample will be collected (on the day of surgery or hospital admission) to analyze laboratory parameters including leukocyte count, C-reactive protein, and neutrophils. Additionally, a urine sample will be collected to determine the levels of prostaglandin E urinary metabolites (PGE-M) and creatinine'}, '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 Surgical Department at the University Hospital of Split', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children of age 5 -17 years with acute abdominal pain\n* children with clinical signs of acute appendicitis\n\nExclusion Criteria:\n\n* previous diagnosis of chronic and/or malignant disease\n* children who had previous abdominal surgery\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT07008092', 'briefTitle': 'Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'KBC Split'}, 'officialTitle': 'Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children', 'orgStudyIdInfo': {'id': '2181-147/01-06/LJ.Z.-25-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute appendicitis with rupture', 'interventionNames': ['Diagnostic Test: Blood specimen collection', 'Diagnostic Test: Urine collection']}, {'label': 'Acute appendicitis without rupture', 'interventionNames': ['Diagnostic Test: Blood specimen collection', 'Diagnostic Test: Urine collection']}, {'label': 'Control group', 'description': 'Patients with abdominal pain in which acute appendicitis has been ruled out as a cause', 'interventionNames': ['Diagnostic Test: Blood specimen collection', 'Diagnostic Test: Urine collection']}], 'interventions': [{'name': 'Blood specimen collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.', 'armGroupLabels': ['Acute appendicitis with rupture', 'Acute appendicitis without rupture', 'Control group']}, {'name': 'Urine collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites', 'armGroupLabels': ['Acute appendicitis with rupture', 'Acute appendicitis without rupture', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Split', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Tomislav Žuvela, MD', 'role': 'CONTACT', 'email': 'tomislav.zuvela29@gmail.com', 'phone': '0919008148'}], 'facility': 'University Hospital of Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'centralContacts': [{'name': 'Tomislav Žuvela, Doctor of Medicine, MD', 'role': 'CONTACT', 'email': 'tomislav.zuvela29@gmail.com', 'phone': '+385919008148'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KBC Split', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Medicine, Plastic surgery resident', 'investigatorFullName': 'Tomislav Žuvela', 'investigatorAffiliation': 'KBC Split'}}}}