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NCT05769829 · ClinicalTrials.gov registry record
ImmuneSense™ IBD Study
A clinical trial, sponsored by Adaptive Biotechnologies.
- Terminated
- Registry status
- 484
- Enrollment target
NCT05769829: Clinical Trial study, sponsored by Adaptive Biotechnologies.
NCT05769829 is a clinical trial that was terminated before completion, run by Adaptive Biotechnologies. The registered enrollment target is 484 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05769829 was terminated before completion, sponsored by Adaptive Biotechnologies.
- TERMINATED
- Registry status
- 484 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2023-08-14 |
Why NCT05769829 stopped before completion
NCT05769829 is an observational study that tracks outcomes without assigning an intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05769829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05769829 about?
NCT05769829 is a clinical study titled "ImmuneSense™ IBD Study". 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...
What is the current status of trial NCT05769829?
This trial is currently terminated. The enrollment target is 484 participants. The study started on 2022-10-31. Estimated completion is 2023-08-14.
Who is sponsoring clinical trial NCT05769829?
This trial is sponsored by Adaptive Biotechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
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