What this study is
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.
Study details
- Sponsor
- Boston Children's Hospital
- Conditions
- Graft Vs Host Disease · Inflammatory Bowel Diseases · Functional Gastrointestinal Disorders
- Enrolling
- 1,000 people
- Starts
- 2017-05-01
- Est. completion
- 2032-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients must be at least 1 month old and weigh >/= 3 kg.
- Patients receiving any allogeneic or autologous hematopoietic stem cell transplantation (bone marrow, peripheral blood, or cord blood transplant).
- Patients and/or parents or legal guardians must sign a written informed consent. B. Inclusion Criteria for Adoptive Cellular Therapy (CT) patients: Weight ≥3 kg
- Patients receiving adoptive cellular therapy
- Patient and/or legal guardian must sign written informed consent C. Inclusion criteria for Healthy Donor Blood volunteers: Age 18+
- Participant does not have signs/symptoms of present illness
- Participant does not have a known disease affecting the immune system
- Participant is not on any medication/s that suppress immune system
- Obtain informed consent D. Inclusion criteria for HCT Related and Unrelated Donors: Age >1 years of age
- Weight >3 kg
- Obtain informed consent E. Inclusion criteria for IBD & FGID patients: Patients must be at least 6 years old and weigh >/= 10 kg.
- Patients being evaluated for IBD (new diagnosis or follow up of established disease), OR; Patients being evaluated for FGID (new diagnosis or follow up of established disease).
- Obtain informed consent F. Inclusion criteria for HCT & Cell Therapy Household Members: Household member of a patient who is receiving HCT or Cell Therapy and who is participating in the PREDICT study
- Age >1 years of age
- Weight >3 kg
- Obtain informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openMassachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Seattle Children's Hospital
Seattle, Washington, United States
Study team
Sponsor
Boston Children's Hospital
Study ID P00030890
Principal investigator
Leslie Kean, MD, PhD
Boston Children's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.