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NCT05093660 Clinical Trial

Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients

Appendicitis Acute Clinical Trial

Official title:
Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein Analysed From Blood and Saliva in Children With Acute Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05093660
Other study ID # 2181-147/01/06/M.S.-20-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date June 30, 2022

Study information
Verified date March 2022
Source KBC Split
Contact Goran Tintor, MD
Phone +38521557111
Email gogitintor@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria: - children with age from 5 do 17 with acute abdominal pain - children with clinical signs of appendicitis Exclusion Criteria: - previous diagnosis of chronic and/or malignant disease - children which had previous abdominal surgery - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood specimen collection
Blood specimen collection for analysis of CRP (C-reactive protein), WBC (White blood cells) and LRG1 (Circulating Human Leucine-rich a-2-glycoprotein) levels
• Saliva specimen collection
Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich a-2-glycoprotein) levels

Locations
Country Name City State
Croatia University Hospital Split Split Splitsko-dalmatinska

Sponsors (1)
Lead Sponsor Collaborator
KBC Split

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of LGR1 protein in blood Levels of LGR1 protein in blood and saliva as measured by ELISA test 72 hours
Primary Level of LGR1 protein saliva Levels of LGR1 protein in saliva as measured by ELISA test 72 hours
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