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NCT04617184 Clinical Trial

Registry and Biorepository for IBD in Central Texas

Ulcerative Colitis Clinical Trial

Official title:
Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04617184
Other study ID # 2019-07-0137
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2030

Study information
Verified date May 2021
Source University of Texas at Austin
Contact Benjamin Chebaa, BA
Phone 5124955641
Email benjamin.chebaa@austin.utexas.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• NO INTERVENTION
THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY

Locations
Country Name City State
United States Dell Medical School, UT Austin Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with inflammatory bowel disease Number of patients with Crohns, ulcerative colitis, and IBD undetermined 10 YEARS
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