Crohn Disease (CD)PREDICTNCT07166588
Research for the Precision Medicine in the Treatment of Inflammatory Bowel Disease
An observational study of Crohn Disease (CD) and Ulcerative Colitis (UC), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to establish an integrated cohort of patients with inflammatory bowel disease (IBD) from Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease)
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2021to 31 Dec 2028
- How long will I take part?
- 72 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
Who may be able to join
- Patients aged 10 years or older who have been newly diagnosed with inflammatory bowel disease or are under follow-up monitoring.
Who cannot join
- Patients diagnosed with cancer or with a history of cancer treatment.
- Participation may be restricted at the discretion of the medical team.
- Infants and young children under the age of 10.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Convergence Research Platform for the Precision Medicine in the Treatment of Inflammatory Bowel Disease
This study aims to establish an integrated cohort of patients with inflammatory bowel disease (IBD) from Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this cohort, we seek to develop a prognostic prediction model for IBD patients and a predictive model for therapeutic responses to biologic agents and small molecule therapies.
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Crohn Disease
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction model in the patients with inflammatory bowel disease for treatment response
Development of a prognostic prediction model for patients with inflammatory bowel disease and a predictive model for therapeutic response to biologic agents and small molecule therapies
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 72 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeongJoon Koh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166588
- Sponsor's protocol ID
- 2012-115-1183
- Acronym
- PREDICT
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convergence Research Platform for the Precision Medicine in the Treatment of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07166588
- Acronym / sponsor ID
- PREDICT / 2012-115-1183
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease, Crohn Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Sep 2025 (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.
This study aims to establish an integrated cohort of patients with inflammatory bowel disease (IBD) from Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this cohort, we seek to develop a prognostic prediction model for IBD patients and a predictive model for therapeutic responses to biologic agents and small molecule therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 72 Months
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
Key inclusion criteria (1 listed)
- Patients aged 10 years or older who have been newly diagnosed with inflammatory bowel disease or are under follow-up monitoring.
Key exclusion criteria (3 listed)
- Patients diagnosed with cancer or with a history of cancer treatment.
- Participation may be restricted at the discretion of the medical team.
- Infants and young children under the age of 10.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction model in the patients with inflammatory bowel disease for treatment response
Time frame: From enrollment to the end of treatment at 12 weeks
Development of a prognostic prediction model for patients with inflammatory bowel disease and a predictive model for therapeutic response to biologic agents and small molecule therapies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Crohn Disease (CD) and Ulcerative Colitis (UC), run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction model in the patients with inflammatory bowel disease for treatment response (time frame: From enrollment to the end of treatment at 12 weeks). 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 15 Sep 2025.