Registry and Biorepository for IBD in Central Texas

Recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases
• Interventions: Other: NO INTERVENTION

• Registration Number: NCT04617184
• Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-18
• Study Start: 2021-06-01
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inflammatory Bowel Disease	NO INTERVENTION	any patient with IBD will be included in the registry

Primary Outcome Measures

Name	Time	Method
Number of patients with inflammatory bowel disease	10 YEARS	Number of patients with Crohns, ulcerative colitis, and IBD undetermined

Trial Locations

Locations (1)

Dell Medical School, UT Austin; 🇺🇸 Austin, Texas, United States