NCT05769829

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

January 11, 2023

Last Update Submit

October 3, 2023

Conditions

Inflammatory Bowel Diseases

Keywords

IBDUlcerative colitisCrohn's disease

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of T-Detect IBD

    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.

    Initial Study visit/Baseline

Secondary Outcomes (1)

  • Future/Additional research

    Initial Study visit/Baseline

Study Arms (4)

Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms

Up to 450 participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy. In addition to the 450 participants enrolled, 50 more participants that meet inclusion/exclusion for cohort 1 will be enrolled to complete only the initial visit and endoscopy visit. Participants will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis.

Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment

Up to 400 participants recently diagnosed with inflammatory bowel disease but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy.

Cohort 3: Potential Cross-Reactive Diseases

Patients will be eligible for this cohort if they fail to be diagnosed with inflammatory bowel disease but have a confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease.

Cohort 4: Healthy Controls

Up to 228 participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • Age \<7 years or \>89 years
  • Known active malignancy
  • Known Celiac disease
  • Active Hepatitis B, C or HIV infection(s)
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hope Clinic & Research Center LLC

Hialeah, Florida, 33010, United States

Location

Gold Coast Health Research Center, LLC

Miami, Florida, 33155, United States

Location

Sanitas Research

Miami, Florida, 33155, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

Location

University Gastroenterology

Providence, Rhode Island, 02904, United States

Location

Gastroenterology Consultants of South Texas, PA

Brownsville, Texas, 78526, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

March 15, 2023

Study Start

October 31, 2022

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

US(6)