Ulcerative Colitis ChronicNUCaCDNCT05189327
Noninterventional Observational Prospective Longitudinal Study of the Incidence of Ulcerative Colitis and Crohn's Disease Among the Adult Population of the Republic of Kazakhstan
An observational study of Ulcerative Colitis Chronic and Crohn Disease Colon, run by Kazakhstan Scientific Society for Study of intestine diseases at 1 site in Kazakhstan.
Trial summary
The NUCaCD study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the Republic of Kazakhstan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis Chronic, Crohn Disease Colon
- How many people
- 2,000 participants
- Where
- 1 siteKazakhstan
- Study dates
- 10 Dec 2021to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a verified diagnosis of Nonspecific Ulcerative Colitis and Crohn Disease.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Primary Health Clinic #5
Almaty
Jamilya Kaibullayeva, PhD, +77471051195, kaibullaev@mail.ru
Ainash Tanabayeva, MD, +77016007565, ainashik@list.ru
About this study
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
The NUCaCD study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the Republic of Kazakhstan.
Read the 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.
- Conditions
- Ulcerative Colitis Chronic, Crohn Disease Colon
- Being tested
- No intervention
- Keywords
- Nonspecific Ulcerative colitis, Crohn Disease, Patient Registry
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease | All patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease in the Republic of Kazakhstan. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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
Measured: 2 years
Analysis of the relationship between management strategies and treatment outcomes
Analysis of the relationship between management strategies and treatment outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kazakhstan Scientific Society for Study of intestine diseases
- Sponsor type
- University, hospital or other
- Collaborators
- FERRING Kazakhstan
- Responsible party
- Sponsor
- Investigators
- Jamilya Kaibullayeva, PhD, Study director, KSSSID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189327
- Sponsor's protocol ID
- KSSSID-052021
- Acronym
- NUCaCD
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05189327
- Acronym / sponsor ID
- NUCaCD / KSSSID-052021
- Conditions
- Ulcerative Colitis Chronic, Crohn Disease Colon
- Keywords
- Nonspecific Ulcerative colitis, Crohn Disease, Patient Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Kazakhstan Scientific Society for Study of intestine diseasesUniversity, hospital or other
- Collaborators
- FERRING Kazakhstan
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease | – | Other: No interventionAll patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease in the Republic of Kazakhstan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a verified diagnosis of Nonspecific Ulcerative Colitis and Crohn Disease.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNon-interventional study | Other | Patients with diagnosed Nonspecific Ulcerative Colitis and Crohn Disease |
Primary outcome
To study the incidence of NUC and CD in the Republic of Kazakhstan
Time frame: 2 years
To study the incidence of NUC and CD in the Republic of Kazakhstan
3 secondary outcomes
To study the patterns of the course of the disease and the treatment effect
Time frame: 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
Time frame: 2 years
Analysis of the relationship between management strategies and treatment outcomes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamilya Kaibullayeva, PhD study director
KSSSID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis Chronic and Crohn Disease Colon, run by Kazakhstan Scientific Society for Study of intestine diseases at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamilya Kaibullayeva, PhD (+77471051195, kaibullaev@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the incidence of NUC and CD in the Republic of Kazakhstan (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.