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

March 29, 2022 updated by: Goran Tintor, KBC Split

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
    • Splitsko-dalmatinska
      • Split, Splitsko-dalmatinska, Croatia, 21000
        • Recruiting
        • University Hospital Split
        • Contact:
          • Zenon Pogorelić, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of LGR1 protein in blood
Time Frame: 72 hours
Levels of LGR1 protein in blood and saliva as measured by ELISA test
72 hours
Level of LGR1 protein saliva
Time Frame: 72 hours
Levels of LGR1 protein in saliva as measured by ELISA test
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KBC Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-147/01/06/M.S.-20-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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