Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT05189327
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the incidence of NUC and CD in the Republic of Kazakhstan', 'timeFrame': '2 years', 'description': 'To study the incidence of NUC and CD in the Republic of Kazakhstan'}], 'secondaryOutcomes': [{'measure': 'To study the patterns of the course of the disease and the treatment effect', 'timeFrame': '2 years', 'description': 'To study the patterns of the course of the disease and the effectiveness of drug therapy in outpatient and inpatient clinics.'}, {'measure': "Conduct an analysis of the completeness of the diagnosis and compliance with the national guidelines for the diagnosis and treatment of ulcerative colitis and Crohn's disease", 'timeFrame': '2 years', 'description': "Conduct an analysis of the completeness of the diagnosis and compliance with the national guidelines for the diagnosis and treatment of ulcerative colitis and Crohn's disease"}, {'measure': 'Analysis of the relationship between management strategies and treatment outcomes', 'timeFrame': '2 years', 'description': 'Analysis of the relationship between management strategies and treatment outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonspecific Ulcerative colitis', 'Crohn Disease', 'Patient Registry'], 'conditions': ['Ulcerative Colitis Chronic', 'Crohn Disease Colon']}, 'descriptionModule': {'briefSummary': 'The NUCaCD study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the Republic of Kazakhstan.', 'detailedDescription': 'The NUCaCD aims to study the prevalence of inflammatory bowel diseases in the Republic of Kazakhstan and create a reliable database, which will greatly facilitate future planning of the volume of health resources needed to address these diseases management and will help to optimize preventive measures and will support future research to better understand the etiology, new options treatment and factors affecting prognosis, relapses, development of complications and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a verified diagnosis of Nonspecific Ulcerative Colitis and Crohn Disease.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Availability of a signed informed consent form; or the presence of a disinterested witness if the patient is unable to examine and sign the consent form due to illiteracy or disability (for example, in the case of blindness);\n* The patient has a documented diagnosis of ulcerative colitis or Crohn's disease (endoscopy, histology, if indicated by radiation diagnostics);\n* Patients who have applied for treatment or are already taking treatment from a gastroenterologist / coloproctologist, including inpatients;\n* Citizenship of the Republic of Kazakhstan (or resides).\n\nExclusion Criteria:\n\n* Patient takes part in an interventional clinical trial;\n* Patient is unable to follow the schedule of the visits;\n* Any condition that the PI believes would prevent a study participant from participating in the study."}, 'identificationModule': {'nctId': 'NCT05189327', 'acronym': 'NUCaCD', 'briefTitle': "Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan", 'organization': {'class': 'OTHER', 'fullName': 'Kazakhstan Scientific Society for Study of intestine diseases'}, 'officialTitle': "Non-interventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan", 'orgStudyIdInfo': {'id': 'KSSSID-052021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease', 'description': 'All patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease in the Republic of Kazakhstan.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almaty', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Jamilya Kaibullayeva, PhD', 'role': 'CONTACT', 'email': 'kaibullaev@mail.ru', 'phone': '+77471051195'}, {'name': 'Ainash Tanabayeva, MD', 'role': 'CONTACT', 'email': 'ainashik@list.ru', 'phone': '+77016007565'}, {'name': 'Jamilya Kaibullayeva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Primary Health Clinic #5', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}], 'centralContacts': [{'name': 'Jamilya Kaibullayeva, PhD', 'role': 'CONTACT', 'email': 'kaibullaev@mail.ru', 'phone': '+77471051195'}, {'name': 'Kanat Khazhidinov, M.Sc.', 'role': 'CONTACT', 'email': 'k.khazhidinov@ksssid.com', 'phone': '+77074138263'}], 'overallOfficials': [{'name': 'Jamilya Kaibullayeva, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KSSSID'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kazakhstan Scientific Society for Study of intestine diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'FERRING Kazakhstan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}