Precision Diagnostics in Inflammatory Bowel Disease, Cellular Therapy and Transplantation (The PREDICT Trial)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03369353
Status
Enrolling By Invitation

Conditions

  • Functional Gastrointestinal Disorders
  • Graft Vs Host Disease
  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of the Precision Diagnosis in Inflammatory Bowel Disease, Cellular Therapies, and Transplantation (PREDICT) trial is to apply a systems-biology approach to enable precision diagnostics for the key immunologic outcomes for patients with Inflammatory Bowel Disease, Cellular Therapeutics and Transplantation. This approach will deepen the understanding of the molecular mechanisms driving auto- and allo-immune diseases and serve as a critical platform upon which to design evidence-based treatment paradigms for these patients. This research study will examine the immunology of auto- and allo-immune gastrointestinal disturbances such as Inflammatory Bowel Disease (IBD), Graft-versus-Host Disease (GVHD), and Functional Gastrointestinal Disorder (FGID), as well as the immune manifestations after CAR-T and other cellular therapeutics. The Investigators seek to use blood and tissue samples in order to better understand the mechanisms driving these diseases and their therapies. The Investigators further hypothesize that longitudinal systems-based immunologic analysis will enable the patient-specific determination of the molecular evolution of IBD, GVHD and the response to cellular therapeutics, as well post-transplant defects in protective immunity, and determine which pathways, when perturbed, can cause clinical disease. The discovery of these pathways will lead to improved diagnostic, prognostic and treatment approaches, and to personalized therapeutic decision-making for these patients.

Key Dates

Start date
May 1, 2017
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2032

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Perform flow cytometry, TCR deep sequencing and whole transcriptome analysis on T cells purified from GI endoscopy samples taken for presumed GI GVHD, inflammatory bowel disease (IBD), and functional gastrointestinal disease (FGID). [ Time Frame: 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MASeattle Children's Hospital· Seattle, WA

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