Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan

Ulcerative Colitis Chronic Clinical Trial

— NUCaCD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189327
• Other study ID #: KSSSID-052021
• Status: Recruiting
• Start date: December 10, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2021
• Source: Kazakhstan Scientific Society for Study of intestine diseases
• Contact: Jamilya Kaibullayeva, PhD
• Phone: +77471051195
• Email: kaibullaev[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer
• Ulcerative Colitis Chronic

Intervention

Other:
• No intervention
Non-interventional study

Locations

Country	Name	City	State
Kazakhstan	Primary Health Clinic #5	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Kazakhstan Scientific Society for Study of intestine diseases	FERRING Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the incidence of NUC and CD in the Republic of Kazakhstan	To study the incidence of NUC and CD in the Republic of Kazakhstan	2 years
Secondary	To study the patterns of the course of the disease and the treatment effect	To study the patterns of the course of the disease and the effectiveness of drug therapy in outpatient and inpatient clinics.	2 years
Secondary	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	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	2 years
Secondary	Analysis of the relationship between management strategies and treatment outcomes	Analysis of the relationship between management strategies and treatment outcomes	2 years