NCT05769829

ImmuneSense™ IBD Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 484 (actual)
• Sponsor: Adaptive Biotechnologies · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Diseases

Timeline

• Start date: 2022-10-31
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2023-03-15
• Last updated: 2023-10-05

Locations

6 sites across 1 country: United States