Clinical trial NCT05189327: Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis Chronic
Crohn Disease Colon
Keywords: Nonspecific Ulcerative colitis
Crohn Disease
Patient Registry
Lead sponsor: Kazakhstan Scientific Society for Study of intestine diseases
Sponsor class: OTHER
Collaborators: name: FERRING Kazakhstan
First posted: 2022-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a verified diagnosis of Nonspecific Ulcerative Colitis and Crohn Disease.

Brief summary: The NUCaCD study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the Republic of Kazakhstan.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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);
* The patient has a documented diagnosis of ulcerative colitis or Crohn's disease (endoscopy, histology, if indicated by radiation diagnostics);
* Patients who have applied for treatment or are already taking treatment from a gastroenterologist / coloproctologist, including inpatients;
* Citizenship of the Republic of Kazakhstan (or resides).

Exclusion Criteria:

* Patient takes part in an interventional clinical trial;
* Patient is unable to follow the schedule of the visits;
* Any condition that the PI believes would prevent a study participant from participating in the study.

Primary outcomes:
measure: To study the incidence of NUC and CD in the Republic of Kazakhstan
timeFrame: 2 years
Secondary outcomes:
measure: To study the patterns of the course of the disease and the treatment effect
timeFrame: 2 years
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
measure: Analysis of the relationship between management strategies and treatment outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Primary Health Clinic #5
Study officials:
affiliation: KSSSID
name: Jamilya Kaibullayeva, PhD
role: STUDY_DIRECTOR
References: