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

Sponsor

KBC Split (Other)

Overall Status

Recruiting

CT.gov ID

NCT05093660

Collaborator

(none)

Enrollment

Location

8.5

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Acute	Diagnostic Test: Blood specimen collection Diagnostic Test: Saliva specimen collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with acute appendicitis Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.	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 α-2-glycoprotein) levels Diagnostic Test: Saliva specimen collection Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels
Patients without acute appendicitis Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.	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 α-2-glycoprotein) levels Diagnostic Test: Saliva specimen collection Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels

Arm

Intervention/Treatment

Patients with acute appendicitis

Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation.

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 α-2-glycoprotein) levels

Diagnostic Test: Saliva specimen collection

Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels

Patients without acute appendicitis

Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance.

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 α-2-glycoprotein) levels

Diagnostic Test: Saliva specimen collection

Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels

Outcome Measures

Primary Outcome Measures

Level of LGR1 protein in blood [72 hours]
Levels of LGR1 protein in blood and saliva as measured by ELISA test
Level of LGR1 protein saliva [72 hours]
Levels of LGR1 protein in saliva as measured by ELISA test

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Split	Split	Splitsko-dalmatinska	Croatia	21000

Sponsors and Collaborators

KBC Split

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Goran Tintor, Plastic surgery resident, KBC Split

ClinicalTrials.gov Identifier:

NCT05093660

Other Study ID Numbers:

2181-147/01/06/M.S.-20-02

First Posted:

Oct 26, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of Apr 7, 2022