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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

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