AppendicitisNCT03988660
The Circulating Fibrocyte - a Novel and Accurate Biomarker in Diagnosing Acute Appendicitis in Adults
An observational study of Appendicitis, run by University Hospital of Limerick at 1 site in Ireland.
Trial summary
Accurate diagnostic biomarkers for acute appendicitis (AA) are lacking. Circulating fibrocytes (CFs) are increased in inflammatory states. It is not known whether they are altered in appendicitis. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Circulating fibrocytes
- How many people
- 95 participants
- Where
- 1 siteIreland
- Study dates
- 10 Jun 2015to 14 Apr 2019
- How long will I take part?
- 14 Days
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy individuals and patients presented to the hospital with suspected appendicitis aged 16 year-old- or more.
Who may be able to join
- Any patient presents with right iliac fossa pain
- Age 16 years old or more
Who cannot join
- Previous appendicectomy
Trial locations and contacts
1 site in 1 country.
About this study
Accurate diagnostic biomarkers for acute appendicitis (AA) are lacking. Circulating fibrocytes (CFs) are increased in inflammatory states. It is not known whether they are altered in appendicitis. This study aimed to assess if CF altered in AA, and compared their diagnostic accuracy with white cell count (WCC), C-reactive protein (CRP), neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils in diagnosis of AA in patients presenting with right iliac fossa pain (RIFP).
95 consecutive adults were recruited in a cohort based prospective study at University Hospital Limerick, 15 were healthy individuals and 80 were patients with RIFP. Peripheral venous samples were obtained at presentation. Clinical, biochemical and histo-pathological parameters were recorded. CF levels were determined by dual-staining for CD45 and Col-1 using FACS and correlated with histopathological diagnoses. P<0.05 was taken as significant.
The study hypothesis is that in patients with suspected appendicitis, CF levels may improve the diagnostics, reduce unnecessary radiation and negative appendicectomy rates.
Read the detailed description
Acute appendicitis (AA) is the commonest abdominal emergency. Despite its high prevalence, the diagnosis of appendicitis remains a challenge. The clinical presentation is frequently atypical and symptoms often overlap with many other conditions. Coupled with this, failure to reach a prompt diagnosis can result in adverse outcomes.
Circulating fibrocytes (CFs) were first described in 1994 by Richard Bucala. They are haematopoietic cells derived from the bone marrow. They circulate in the monocyte fraction and can differentiate into myelofibrocytes, fibroblasts and adipocytes (among other cell types). They have a prominent role in inflammatory and healing processes, and in the development of fibrosis.
No studies to date have examined the role of CFs in acute appendicitis. Thus, the aims of this clinical trial were (1) to determine if CFs are altered in acute appendicitis, (2) to assess and compare their diagnostic accuracy with CRP, WCC, neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils, and (3) to determine the most reliable predictors in diagnosing AA.
A prospective cohort study was undertaken to (1) determine circulating fibrocytes levels (CF) in patients with histologically confirmed acute appendicitis (AA), and (2) to determine the sensitivity and specificity of circulating CF levels in the diagnosis of AA, in adults (age ≥ 16 years) presenting acutely with right iliac fossa pain, at the University hospital Limerick. The diagnosis of appendicitis was confirmed by histopathological assessment following appendicectomy.
Patients were divided in three cohorts following their final diagnosis on discharge and based on the histopathology results. (1) patients with RIFP who underwent an appendicectomy and had a normal appendix at histological assessment i.e histologically proven normal appendix group (HPNG). (2) patients with RIFP who underwent an appendicectomy and had an inflamed appendix at histological assessment i.e histologically proven appendicitis group (HPAG). (3) patients with RIFP who had an alternate diagnosis on discharge other than appendicitis i.e alternative diagnosis group (ADG). Another cohort was added as (4) healthy controls.
Data collected included date of admission, patient's gender, age, presenting symptoms, duration of symptoms, CF levels, preoperative WCC and its differentials (neutrophil, lymphocyte, neutrophils-lymphocytes ratio (NLR), monocyte, basophil and eosinophil counts), CRP, final clinical diagnosis, operation and post-operative diagnosis based at histological assessment.
Peripheral venous samples were obtained from patients in cohort 1, 2 and 3 (n= 80) and healthy controls (n=15). A single 10 mL sample of heparinized venous blood was collected via peripheral, upper extremity venipuncture. Samples were collected in sodium heparin (EDTA) vacutainer tubes and transferred to the laboratory within 3 hours. Samples were then processed to isolate the buffy coat layer using density gradient centrifugation (Histopaque, Sigma-Aldrich, Wicklow, Ireland). The resulting peripheral blood mononuclear cells were subsequently washed in Phosphate-buffered saline (PBS) and re-suspended in freezing medium (50% foetal bovine serum, 40% RPMI medium and 10% dimethyl sulfoxide) prior to transfer to cryogenic vials in 1-ml aliquots. Finally, samples were cooled in a cryogenic temperature control rate container to -80 °C until processing for flow cytometry. Following white blood cell isolation using density gradient centrifugation, 1×106cells were re-suspended in flow cytometry buffer (RPMI medium supplemented with 10% horse serum, 0.1% sodium azide and 25 mM HEPES). Cells were fixed and permeabilised using BD Cytofix/Cytoperm solution (BD Biosciences, Oxford, England) and blocked prior to intracellular staining of Collagen-I with mouse anti-human Collagen-I antibody (Millipore, Cork, Ireland, Product code MAB3391) which was subsequently stained with Alexa-Fluor 488 goat anti-mouse secondary antibody (Jackson ImmunoResearch Europe, Suffolk, England; Product code 115-545-146). Cells were then stained for cell surface antigen CD45 using PerCP anti-human CD45 (Biolegend, London, England). Cells were then re-suspended in PBS before subsequent analysis on the flow cytometer (BD FACSVerse). All analysis was done on a BD FACSVerse (BD Biosciences) using BD FACSuite v1.0.5 (BD Biosciences). Fibrocyte levels were displayed as a percentage of the total white blood cell population.
Data analyses were performed using IBM SPSS for Mac OSX version 25.0. Data were presented as means and standard deviations, or medians and interquartile ranges, as appropriate. Distribution of variables was assessed by histograms, Q-Q plots, and box plots. Analysis of Variance (One-Way ANOVA) was used to compare between different independent groups. Kruskal-Wallis test was used to compare between the biomarkers and the different groups (HPNG vs. HPAG vs. ADG), and for subgroup analysis pairwise comparisons were performed, a P - value of less than 0.05 was considered statistically significant. Receiver operating characteristic (ROC) curve was used to characterize and compare between the diagnostic accuracy of CFs, WCC, CRP, neutrophils, NLR and monocytes. Multinomial logistic regression analysis was used to assess for independent predictors for AA.
- Conditions
- Appendicitis
- Being tested
- Circulating fibrocytes
- Keywords
- Appendicitis, Fibrocytes, Biomarker
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating fibrocytesDiagnostic test
Also called White Cell Counts, C-reactive protein, Neutrophils, Lymphocytes, Neutrophil-lymphocyte ratio, Monocytes, Basophils and Eosinophils
Peripheral blood samples were taken from the patients presented with right iliac fossa pain. Samples were collected in sodium heparin (EDTA). Circulating fibrocyte levels were determined by dual staining peripheral blood samples for CD4 and Col-1 using Fluorescence-Activated Cell Sorting (FACS) and correlated with histopathological diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy individuals Receives: Diagnostic Test: Circulating fibrocytes | |
| Histologically confirmed appendicitis | Patients who have diagnosis of appendicitis on histology Receives: Diagnostic Test: Circulating fibrocytes | |
| Histologically normal appendix | Patients who have diagnosis of a normal appendix on histology Receives: Diagnostic Test: Circulating fibrocytes | |
| Alternative diagnosis group | Patients who diagnosed with a condition other than appendicitis Receives: Diagnostic Test: Circulating fibrocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients who have acute appendicitis
The outcome was assessed by histo-pathology analysis post-operatively
Measured: 14 days
Incidence of normal appendix
The outcome was assessed by histo-pathology analysis post-operatively
Measured: 14 days
Incidence of patients with alternative diagnosis
The outcome was assessed clinically following admission
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start10 Jun 2015
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies 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
- 95 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zarog, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988660
- Sponsor's protocol ID
- University of Limerick
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zarog M, O'Leary P, Kiernan M, Bolger J, Tibbitts P, Coffey S, Byrnes G, Peirce C, Dunne C, Coffey C. Circulating fibrocyte percentage and neutrophil-lymphocyte ratio are accurate biomarkers of uncomplicated and complicated appendicitis: a prospective cohort study. Int J Surg. 2023 Mar 1;109(3):343-351. doi: 10.1097/JS9.0000000000000234.
PubMed 37093074
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Circulating Fibrocyte - a Novel and Accurate Biomarker in Diagnosing Acute Appendicitis in Adults
- ClinicalTrials.gov ID
- NCT03988660
- Acronym / sponsor ID
- University of Limerick
- Conditions
- Appendicitis
- Keywords
- Appendicitis, Fibrocytes, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 17 Jun 2019 (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.
Accurate diagnostic biomarkers for acute appendicitis (AA) are lacking. Circulating fibrocytes (CFs) are increased in inflammatory states. It is not known whether they are altered in appendicitis. This study aimed to assess if CF altered in AA, and compared their diagnostic accuracy with white cell count (WCC), C-reactive protein (CRP), neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils in diagnosis of AA in patients presenting with right iliac fossa pain (RIFP).
95 consecutive adults were recruited in a cohort based prospective study at University Hospital Limerick, 15 were healthy individuals and 80 were patients with RIFP. Peripheral venous samples were obtained at presentation. Clinical, biochemical and histo-pathological parameters were recorded. CF levels were determined by dual-staining for CD45 and Col-1 using FACS and correlated with histopathological diagnoses. P<0.05 was taken as significant.
The study hypothesis is that in patients with suspected appendicitis, CF levels may improve the diagnostics, reduce unnecessary radiation and negative appendicectomy rates.
Detailed description
Acute appendicitis (AA) is the commonest abdominal emergency. Despite its high prevalence, the diagnosis of appendicitis remains a challenge. The clinical presentation is frequently atypical and symptoms often overlap with many other conditions. Coupled with this, failure to reach a prompt diagnosis can result in adverse outcomes.
Circulating fibrocytes (CFs) were first described in 1994 by Richard Bucala. They are haematopoietic cells derived from the bone marrow. They circulate in the monocyte fraction and can differentiate into myelofibrocytes, fibroblasts and adipocytes (among other cell types). They have a prominent role in inflammatory and healing processes, and in the development of fibrosis.
No studies to date have examined the role of CFs in acute appendicitis. Thus, the aims of this clinical trial were (1) to determine if CFs are altered in acute appendicitis, (2) to assess and compare their diagnostic accuracy with CRP, WCC, neutrophils, lymphocytes, neutrophils-lymphocytes ratio (NLR), monocytes, basophils and eosinophils, and (3) to determine the most reliable predictors in diagnosing AA.
A prospective cohort study was undertaken to (1) determine circulating fibrocytes levels (CF) in patients with histologically confirmed acute appendicitis (AA), and (2) to determine the sensitivity and specificity of circulating CF levels in the diagnosis of AA, in adults (age ≥ 16 years) presenting acutely with right iliac fossa pain, at the University hospital Limerick. The diagnosis of appendicitis was confirmed by histopathological assessment following appendicectomy.
Patients were divided in three cohorts following their final diagnosis on discharge and based on the histopathology results. (1) patients with RIFP who underwent an appendicectomy and had a normal appendix at histological assessment i.e histologically proven normal appendix group (HPNG). (2) patients with RIFP who underwent an appendicectomy and had an inflamed appendix at histological assessment i.e histologically proven appendicitis group (HPAG). (3) patients with RIFP who had an alternate diagnosis on discharge other than appendicitis i.e alternative diagnosis group (ADG). Another cohort was added as (4) healthy controls.
Data collected included date of admission, patient's gender, age, presenting symptoms, duration of symptoms, CF levels, preoperative WCC and its differentials (neutrophil, lymphocyte, neutrophils-lymphocytes ratio (NLR), monocyte, basophil and eosinophil counts), CRP, final clinical diagnosis, operation and post-operative diagnosis based at histological assessment.
Peripheral venous samples were obtained from patients in cohort 1, 2 and 3 (n= 80) and healthy controls (n=15). A single 10 mL sample of heparinized venous blood was collected via peripheral, upper extremity venipuncture. Samples were collected in sodium heparin (EDTA) vacutainer tubes and transferred to the laboratory within 3 hours. Samples were then processed to isolate the buffy coat layer using density gradient centrifugation (Histopaque, Sigma-Aldrich, Wicklow, Ireland). The resulting peripheral blood mononuclear cells were subsequently washed in Phosphate-buffered saline (PBS) and re-suspended in freezing medium (50% foetal bovine serum, 40% RPMI medium and 10% dimethyl sulfoxide) prior to transfer to cryogenic vials in 1-ml aliquots. Finally, samples were cooled in a cryogenic temperature control rate container to -80 °C until processing for flow cytometry. Following white blood cell isolation using density gradient centrifugation, 1×106cells were re-suspended in flow cytometry buffer (RPMI medium supplemented with 10% horse serum, 0.1% sodium azide and 25 mM HEPES). Cells were fixed and permeabilised using BD Cytofix/Cytoperm solution (BD Biosciences, Oxford, England) and blocked prior to intracellular staining of Collagen-I with mouse anti-human Collagen-I antibody (Millipore, Cork, Ireland, Product code MAB3391) which was subsequently stained with Alexa-Fluor 488 goat anti-mouse secondary antibody (Jackson ImmunoResearch Europe, Suffolk, England; Product code 115-545-146). Cells were then stained for cell surface antigen CD45 using PerCP anti-human CD45 (Biolegend, London, England). Cells were then re-suspended in PBS before subsequent analysis on the flow cytometer (BD FACSVerse). All analysis was done on a BD FACSVerse (BD Biosciences) using BD FACSuite v1.0.5 (BD Biosciences). Fibrocyte levels were displayed as a percentage of the total white blood cell population.
Data analyses were performed using IBM SPSS for Mac OSX version 25.0. Data were presented as means and standard deviations, or medians and interquartile ranges, as appropriate. Distribution of variables was assessed by histograms, Q-Q plots, and box plots. Analysis of Variance (One-Way ANOVA) was used to compare between different independent groups. Kruskal-Wallis test was used to compare between the biomarkers and the different groups (HPNG vs. HPAG vs. ADG), and for subgroup analysis pairwise comparisons were performed, a P - value of less than 0.05 was considered statistically significant. Receiver operating characteristic (ROC) curve was used to characterize and compare between the diagnostic accuracy of CFs, WCC, CRP, neutrophils, NLR and monocytes. Multinomial logistic regression analysis was used to assess for independent predictors for AA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Circulating fibrocytesHealthy individuals |
| Histologically confirmed appendicitis | – | Diagnostic Test: Circulating fibrocytesPatients who have diagnosis of appendicitis on histology |
| Histologically normal appendix | – | Diagnostic Test: Circulating fibrocytesPatients who have diagnosis of a normal appendix on histology |
| Alternative diagnosis group | – | Diagnostic Test: Circulating fibrocytesPatients who diagnosed with a condition other than appendicitis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy individuals and patients presented to the hospital with suspected appendicitis aged 16 year-old- or more.
Key inclusion criteria (2 listed)
- Any patient presents with right iliac fossa pain
- Age 16 years old or more
Key exclusion criteria (1 listed)
- Previous appendicectomy
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 |
|---|---|---|
| Circulating fibrocytesAlso: White Cell Counts, C-reactive protein, Neutrophils, Lymphocytes, Neutrophil-lymphocyte ratio, Monocytes, Basophils and EosinophilsPeripheral blood samples were taken from the patients presented with right iliac fossa pain. Samples were collected in sodium heparin (EDTA). Circulating fibrocyte levels were determined by dual staining peripheral blood samples for CD4 and Col-1 using Fluorescence-Activated Cell Sorting (FACS) and correlated with histopathological diagnosis. | Diagnostic test | Alternative diagnosis group, Healthy controls, Histologically confirmed appendicitis, Histologically normal appendix |
Primary outcome
Incidence of patients who have acute appendicitis
Time frame: 14 days
The outcome was assessed by histo-pathology analysis post-operatively
Incidence of normal appendix
Time frame: 14 days
The outcome was assessed by histo-pathology analysis post-operatively
Incidence of patients with alternative diagnosis
Time frame: 3 days
The outcome was assessed clinically following admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Derived from this study: PubMed 37093074Zarog M, O'Leary P, Kiernan M, Bolger J, Tibbitts P, Coffey S, Byrnes G, Peirce C, Dunne C, Coffey C. Circulating fibrocyte percentage and neutrophil-lymphocyte ratio are accurate biomarkers of uncomplicated and complicated appendicitis: a prospective cohort study. Int J Surg. 2023 Mar 1;109(3):343-351. doi: 10.1097/JS9.0000000000000234.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Hospital of Limerick at 1 site in Ireland.
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 1 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: finished, as of the sponsor's last update on 17 Jun 2019. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients who have acute appendicitis (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988660, which also lists 1 linked publication.
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 17 Jun 2019.