Inflammatory Bowel DiseasesNCT04558658
Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Complete Blood Count
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2022
- How long will I take part?
- 1 Year
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed IBD by endoscopy, clinical , biochemical correlation and histopathological biopsy
Who may be able to join
- patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy
Who cannot join
- patients have :
- Appendicitis
- sigmoid diverticular disease
- Infectious colitis
- patients known to have cancer colon
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease in Assiut University Hospitals
Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio
Read the detailed description
Inflammatory bowel disease (IBD) has been a global healthcare problem with a sustained increasing incidence. It includes two major forms, Crohn's disease (CD) and ulcerative colitis (UC), which are distinct chronic bowel-relapsing inflammatory disorders (Gharagozloo et al., 2015). Ulcerative colitis (UC) is limitd to Mucosa and cause continuous bowel inflammation (Celikbilek et al., 2013) While Crohn disease is more complex because of its transmural inflammation and it is characterized by skip lesions, which are diseased sections of bowel next to uninvolved areas(Nishijima David L; Wisner, David H; Holmes, James F, 2016). The prevalence of IBD is highest in the second to third decade of life with another peak in the 60-70- year-old group.(Silva et al., 2016) Non-invasive tests, such as C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cells (WBC) are therefore being increasingly recognized as important markers for initial diagnosis and disease activity detection.(Gao et al., 2015) In recent years, the neutrophil-to-lymphocyte ratio (NLR), calculated as total neutrophil count divided by total lymphocyte count, NLR represents two different immune pathways and can be easily derived directly from a standard blood test..(Argeny et al., 2018)
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Complete Blood Count
- Keywords
- neutrophil to lymphocyte ratio
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Blood CountDiagnostic test
neutrophil to lymphocyte ratio
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to lymphocyte ratio in IBD
Determination of the prognostic value of N/L ratio in patients with IBD as a non invasive measure of disease acitivity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558658
- Sponsor's protocol ID
- N/L ratio in IBD activity
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Argeny S, Stift A, Bergmann M, Mittlbock M, Maschke S, Yang Y, Chitsabesan P, Riss S. Prognostic value of preoperative neutrophil-to-lymphocyte ratio in Crohn's disease. Wien Klin Wochenschr. 2018 Jun;130(11-12):398-403. doi: 10.1007/s00508-018-1322-3. Epub 2018 Feb 12.
PubMed 29435759Celikbilek M, Dogan S, Ozbakir O, Zararsiz G, Kucuk H, Gursoy S, Yurci A, Guven K, Yucesoy M. Neutrophil-lymphocyte ratio as a predictor of disease severity in ulcerative colitis. J Clin Lab Anal. 2013 Jan;27(1):72-6. doi: 10.1002/jcla.21564. Epub 2013 Jan 4.
PubMed 23292894Gao SQ, Huang LD, Dai RJ, Chen DD, Hu WJ, Shan YF. Neutrophil-lymphocyte ratio: a controversial marker in predicting Crohn's disease severity. Int J Clin Exp Pathol. 2015 Nov 1;8(11):14779-85. eCollection 2015.
PubMed 26823804
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04558658
- Acronym / sponsor ID
- N/L ratio in IBD activity
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- neutrophil to lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 22 Sep 2020 (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.
Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio
Detailed description
Inflammatory bowel disease (IBD) has been a global healthcare problem with a sustained increasing incidence. It includes two major forms, Crohn's disease (CD) and ulcerative colitis (UC), which are distinct chronic bowel-relapsing inflammatory disorders (Gharagozloo et al., 2015). Ulcerative colitis (UC) is limitd to Mucosa and cause continuous bowel inflammation (Celikbilek et al., 2013) While Crohn disease is more complex because of its transmural inflammation and it is characterized by skip lesions, which are diseased sections of bowel next to uninvolved areas(Nishijima David L; Wisner, David H; Holmes, James F, 2016). The prevalence of IBD is highest in the second to third decade of life with another peak in the 60-70- year-old group.(Silva et al., 2016) Non-invasive tests, such as C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cells (WBC) are therefore being increasingly recognized as important markers for initial diagnosis and disease activity detection.(Gao et al., 2015) In recent years, the neutrophil-to-lymphocyte ratio (NLR), calculated as total neutrophil count divided by total lymphocyte count, NLR represents two different immune pathways and can be easily derived directly from a standard blood test..(Argeny et al., 2018)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed IBD by endoscopy, clinical , biochemical correlation and histopathological biopsy
Key inclusion criteria (1 listed)
- patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy
Key exclusion criteria (5 listed)
- patients have :
- Appendicitis
- sigmoid diverticular disease
- Infectious colitis
- patients known to have cancer colon
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 |
|---|---|---|
| Complete Blood Countneutrophil to lymphocyte ratio | Diagnostic test | – |
Primary outcome
Neutrophil to lymphocyte ratio in IBD
Time frame: baseline
Determination of the prognostic value of N/L ratio in patients with IBD as a non invasive measure of disease acitivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Background: PubMed 29435759Argeny S, Stift A, Bergmann M, Mittlbock M, Maschke S, Yang Y, Chitsabesan P, Riss S. Prognostic value of preoperative neutrophil-to-lymphocyte ratio in Crohn's disease. Wien Klin Wochenschr. 2018 Jun;130(11-12):398-403. doi: 10.1007/s00508-018-1322-3. Epub 2018 Feb 12.
- Background: PubMed 23292894Celikbilek M, Dogan S, Ozbakir O, Zararsiz G, Kucuk H, Gursoy S, Yurci A, Guven K, Yucesoy M. Neutrophil-lymphocyte ratio as a predictor of disease severity in ulcerative colitis. J Clin Lab Anal. 2013 Jan;27(1):72-6. doi: 10.1002/jcla.21564. Epub 2013 Jan 4.
- Background: PubMed 26823804Gao SQ, Huang LD, Dai RJ, Chen DD, Hu WJ, Shan YF. Neutrophil-lymphocyte ratio: a controversial marker in predicting Crohn's disease severity. Int J Clin Exp Pathol. 2015 Nov 1;8(11):14779-85. eCollection 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
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 1 inclusion and 5 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Khaled (01005897058, ak0555012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil to lymphocyte ratio in IBD (time frame: baseline). 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 NCT04558658, which also lists 3 linked publications.
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 22 Sep 2020.