Crohn DiseaseNCT04617184
Registry and Biorepository for IBD in Central Texas
An observational study of Crohn Disease and Ulcerative Colitis, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2030
- How long will I take part?
- 10 Years
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with a diagnosis or suspected diagnosis of IBD made by the treating medical team will be considered for recruitment and enrollment. No special populations are targeted for accrual to this study.
Who may be able to join
- Male or female, age 18 years or older
- Willing and able to provide written consent for participation in the registry and biorepository
- Patients with known or suspected inflammatory bowel disease
Who cannot join
- Patient is unable to comprehend and/or cooperate with study activities
- Patient is too ill to provide consent
- Coagulopathy that precludes safe biopsy of the bowel
- Comorbidity that precludes safe participation in endoscopic procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dell Medical School, UT Austin
Austin, Texas, 78712
Banjamin Chebaa, BA, 512-495-5641, benjamin.chebaa@austin.utexas.edu
About this study
Official title: Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas
This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.
- Being tested
- NO INTERVENTION
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease | any patient with IBD will be included in the registry Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with inflammatory bowel disease
Number of patients with Crohns, ulcerative colitis, and IBD undetermined
Measured: 10 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Anne Feagins, MD, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617184
- Sponsor's protocol ID
- 2019-07-0137
- Status last verified
- May 2021
- First submitted
- 2 Nov 2020
- Last updated
- 18 May 2021
- 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 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas
- ClinicalTrials.gov ID
- NCT04617184
- Acronym / sponsor ID
- 2019-07-0137
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Nov 2020 (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 is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | Other: NO INTERVENTIONany patient with IBD will be included in the registry |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with a diagnosis or suspected diagnosis of IBD made by the treating medical team will be considered for recruitment and enrollment. No special populations are targeted for accrual to this study.
Key inclusion criteria (3 listed)
- Male or female, age 18 years or older
- Willing and able to provide written consent for participation in the registry and biorepository
- Patients with known or suspected inflammatory bowel disease
Key exclusion criteria (4 listed)
- Patient is unable to comprehend and/or cooperate with study activities
- Patient is too ill to provide consent
- Coagulopathy that precludes safe biopsy of the bowel
- Comorbidity that precludes safe participation in endoscopic procedures
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 INTERVENTIONTHERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY | Other | Inflammatory Bowel Disease |
Primary outcome
Number of patients with inflammatory bowel disease
Time frame: 10 YEARS
Number of patients with Crohns, ulcerative colitis, and IBD undetermined
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 18 May 2021.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
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 and Ulcerative Colitis, run by University of Texas at Austin at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 May 2021. 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 United States. 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?
Contact Benjamin Chebaa, BA (5124955641, benjamin.chebaa@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with inflammatory bowel disease (time frame: 10 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 18 May 2021.