Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT04558658
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2020-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil to lymphocyte ratio in IBD', 'timeFrame': 'baseline', 'description': 'Determination of the prognostic value of N/L ratio in patients with IBD as a non invasive measure of disease acitivity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neutrophil to lymphocyte ratio'], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '29435759', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '23292894', 'type': 'BACKGROUND', 'citation': 'Celikbilek 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.'}, {'pmid': '26823804', 'type': 'BACKGROUND', 'citation': "Gao 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."}]}, 'descriptionModule': {'briefSummary': 'Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio', 'detailedDescription': "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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed IBD by endoscopy, clinical , biochemical correlation and histopathological biopsy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy\n\nExclusion Criteria:\n\n* patients have :\n* Appendicitis\n* sigmoid diverticular disease\n* Infectious colitis\n* patients known to have cancer colon'}, 'identificationModule': {'nctId': 'NCT04558658', 'briefTitle': 'Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease in Assiut University Hospitals', 'orgStudyIdInfo': {'id': 'N/L ratio in IBD activity'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Complete Blood Count', 'type': 'DIAGNOSTIC_TEST', 'description': 'neutrophil to lymphocyte ratio'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Khaled', 'role': 'CONTACT', 'email': 'ak0555012@gmail.com', 'phone': '01005897058'}, {'name': 'Wael Abbas', 'role': 'CONTACT', 'email': 'Drwaelabbas@yahoo.com', 'phone': '01064236064'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Evaluation of neutrophil-to-lymphocyte ratio in inflammatory bowel disease in assuit university hospitals', 'investigatorFullName': 'Ahmed Khaled Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}