Clinical trial NCT05769829: ImmuneSense™ IBD Study
Official title: ImmuneSense™ IBD Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Diseases
Keywords: IBD
Ulcerative colitis
Crohn's disease
Lead sponsor: Adaptive Biotechnologies
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms Participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis.

Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment Participants recently diagnosed with IBD but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached.

Cohort 3: Potential Cross-Reactive Diseases Participants with confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease.

Cohort 4: Healthy Controls Participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness.

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.


Eligibility 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

Exclusion Criteria

* Age \<7 years or \>89 years
* Known active malignancy
* Known Celiac disease
* Active Hepatitis B, C or HIV infection(s)
* Active gastrointestinal infection within 30 days prior to enrollment
* 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)
* On any treatment for IBD- systemic corticosteroids within 30 days, immunomodulator, 5-ASA, biologic therapy
* Plan to initiate therapy as part of a clinical trial of a non-FDA-approved IBD therapy

Cohort 3: Potential Cross-Reactive Disease States Inclusion criteria

* Confirmed, documented diagnoses for one of the following diseases:
* Irritable Bowel Syndrome, Functional Diarrhea (Endoscopy negative for inflammation)
* Celiac disease (Serology positive (ttg IgA+) AND Upper endoscopy confirming Celiac disease diagnosis)
* Diverticulitis, and other forms of microscopic colitis
* Infectious etiologies: E. coli, Klebsiella pneumoniae, Salmonella spp., Shigella spp., Yersinia spp (Positive stool culture or PCR)
* For infections, active infections are required or within 30 days of infection.
* 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

Exclusion Criteria

* Age \<7 years or \>89
* Individuals with a prior or current clinical diagnosis of IBD
* Active Hepatitis B, C or HIV infection(s)
* 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 4: Healthy Controls Inclusion criteria

* 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 Exclusion criteria
* Age \<7 years or \>89
* GI symptoms in last 90 days (Abdominal pain, diarrhea, blood in stool, weight loss, vomiting)
* Individuals with a prior or current clinical diagnosis of IBD, Celiac disease, active infection
* Family history of Crohn's disease, indeterminate colitis or ulcerative colitis
* Active Hepatitis B, C or HIV infection(s)
* 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)

Primary outcomes:
measure: Sensitivity and specificity of T-Detect IBD
timeFrame: Initial Study visit/Baseline
Secondary outcomes:
measure: Future/Additional research
timeFrame: Initial Study visit/Baseline
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Hope Clinic & Research Center LLC
state: Florida
city: Miami
country: United States
facility: Gold Coast Health Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Sanitas Research
state: Florida
city: Uniontown
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Brownsville
country: United States
facility: Gastroenterology Consultants of South Texas, PA
state: Texas
Study officials:
References: