Appendicitis AcuteNCT05093660
Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients
An observational study of Appendicitis Acute, run by KBC Split at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Blood specimen collection and Saliva specimen collection
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Oct 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- children with age from 5 do 17 with acute abdominal pain
- children with clinical signs of appendicitis
Who cannot join
- previous diagnosis of chronic and/or malignant disease
- children which had previous abdominal surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Split
Split, Split-Dalmatia County, 21000
Zenon Pogorelić, MD, PhD
About this study
Official title: 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.
- Conditions
- Appendicitis Acute
- Being tested
- Blood specimen collection, Saliva specimen collection
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimen collectionDiagnostic test
Blood specimen collection for analysis of CRP (C-reactive protein), WBC (White blood cells) and LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels
Saliva specimen collectionDiagnostic test
Saliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute appendicitis | Patients with acute appendicitis, after surgery and with pathohistological specimen confirmation. Receives: Diagnostic Test: Blood specimen collection; Diagnostic Test: Saliva specimen collection | |
| Patients without acute appendicitis | Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance. Receives: Diagnostic Test: Blood specimen collection; Diagnostic Test: Saliva specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of LGR1 protein in blood
Levels of LGR1 protein in blood and saliva as measured by ELISA test
Measured: 72 hours
Level of LGR1 protein saliva
Levels of LGR1 protein in saliva as measured by ELISA test
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KBC Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Tintor, KBC Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093660
- Sponsor's protocol ID
- 2181-147/01/06/M.S.-20-02
- Status last verified
- Mar 2022
- First submitted
- 19 Sep 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein Analysed From Blood and Saliva in Children With Acute Appendicitis
- ClinicalTrials.gov ID
- NCT05093660
- Acronym / sponsor ID
- 2181-147/01/06/M.S.-20-02
- Conditions
- Appendicitis Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- KBC SplitUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute appendicitis | – | Diagnostic Test: Blood specimen collection, Diagnostic Test: Saliva specimen collectionPatients with acute appendicitis, after surgery and with pathohistological specimen confirmation. |
| Patients without acute appendicitis | – | Diagnostic Test: Blood specimen collection, Diagnostic Test: Saliva specimen collectionPatients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- children with age from 5 do 17 with acute abdominal pain
- children with clinical signs of appendicitis
Key exclusion criteria (3 listed)
- previous diagnosis of chronic and/or malignant disease
- children which had previous abdominal surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood specimen collectionBlood 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 | Patients with acute appendicitis, Patients without acute appendicitis |
| Saliva specimen collectionSaliva specimen collection for analysis of LRG1 (Circulating Human Leucine-rich α-2-glycoprotein) levels | Diagnostic test | Patients with acute appendicitis, Patients without acute appendicitis |
Primary outcome
Level of LGR1 protein in blood
Time frame: 72 hours
Levels of LGR1 protein in blood and saliva as measured by ELISA test
Level of LGR1 protein saliva
Time frame: 72 hours
Levels of LGR1 protein in saliva as measured by ELISA test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by KBC Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goran Tintor, MD (+38521557111, gogitintor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of LGR1 protein in blood (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.