Inflammatory Bowel Diseases
Conditions
Keywords
IBD, Ulcerative colitis, Crohn's disease
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.
Interventions
None listed
Sponsors
Adaptive Biotechnologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Cohort 1: Pre-diagnosis/+GI symptoms Inclusion criteria * i.GI symptoms with clinical suspicion for inflammation and planned for endoscopy at discretion of clinician * ii. Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study * iii. Must be able to communicate with the investigator, understand and comply with the requirements of the study
Exclusion criteria
* Age \<7 years or \>89 years * Known IBD (Ulcerative colitis, Crohn's disease, indeterminate colitis) and Celiac * Known active malignancy * Active Hepatitis B, C or HIV infection(s) * Use of systemic high dose corticosteroids (above 20mg/day prednisone by mouth) within 30 days prior to the blood draw * Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state * Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study * Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator) Cohort 2: Diagnosed IBD, Pre-treatment Inclusion criteria * Diagnosis of Crohn's disease or Ulcerative colitis made with endoscopy (within 6 months), clinical, imaging, and histological findings. * Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study * Must be able to communicate with the investigator, understand and comply with the requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed