Registry and Biorepository for IBD in Central Texas

NCT04617184 | Recruiting

• 1 other identifier: 2019-07-0137
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Number of patients with inflammatory bowel disease

  Number of patients with Crohns, ulcerative colitis, and IBD undetermined

  10 YEARS

Study Arms (1)

Inflammatory Bowel Disease

any patient with IBD will be included in the registry

Other: NO INTERVENTION

Interventions

NO INTERVENTION OTHER

THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY

Inflammatory Bowel Disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Medical School, UT Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Benjamin Chebaa, BA

CONTACT

5124955641; benjamin.chebaa@austin.utexas.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

US (1)