ImmuneSense™ IBD Study

Terminated

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT05769829
• Lead Sponsor: Adaptive Biotechnologies

Brief Summary

This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.

Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only.

CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls.

AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of T-Detect IBD	Initial Study visit/Baseline	To evaluate the sensitivity and specificity of T-Detect IBD, by interrogating the peripheral T cell repertoire for TCRs enhanced in IBD, to aid in diagnosis of IBD.; To evaluate the sensitivity and specificity of T-Detect IBD relative to endoscopy with biopsies.; To evaluate the sensitivity and specificity of T-Detect IBD as a prognostic marker for medication response.

Secondary Outcome Measures

Name	Time	Method
Future/Additional research	Initial Study visit/Baseline	Samples not allocated to primary objective may be used for additional research and/or development, and clinical and analytical development/validation efforts may utilize samples collected from this study.

Trial Locations

Locations (6)

University Gastroenterology; 🇺🇸 Providence, Rhode Island, United States

Frontier Clinical Research, LLC; 🇺🇸 Uniontown, Pennsylvania, United States

Gastroenterology Consultants of South Texas, PA; 🇺🇸 Brownsville, Texas, United States

Hope Clinic & Research Center LLC; 🇺🇸 Hialeah, Florida, United States

Gold Coast Health Research Center, LLC; 🇺🇸 Miami, Florida, United States

Sanitas Research; 🇺🇸 Miami, Florida, United States