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

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

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

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis Chronic; Crohn Disease Colon
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jamilya Kaibullayeva, PhD; Phone Number: +77471051195; Email: kaibullaev@mail.ru
• Study Contact Backup: Name: Kanat Khazhidinov, M.Sc.; Phone Number: +77074138263; Email: k.khazhidinov@ksssid.com

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • Recruiting
    • Primary Health Clinic #5
    • Contact: Jamilya Kaibullayeva, PhD; Phone Number: +77471051195; Email: kaibullaev@mail.ru
    • Contact: Ainash Tanabayeva, MD; Phone Number: +77016007565; Email: ainashik@list.ru
    • Principal Investigator: Jamilya Kaibullayeva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a verified diagnosis of Nonspecific Ulcerative Colitis and Crohn Disease.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease; All patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease in the Republic of Kazakhstan.	Other: No intervention; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Analysis of the relationship between management strategies and treatment outcomes	Analysis of the relationship between management strategies and treatment outcomes	2 years

Collaborators and Investigators

• Sponsor: Kazakhstan Scientific Society for Study of intestine diseases
• Collaborators: FERRING Kazakhstan
• Investigators: Study Director: Jamilya Kaibullayeva, PhD, KSSSID

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Crohn Disease; Nonspecific Ulcerative colitis; Patient Registry
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: KSSSID-052021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No