Precision Diagnostics in Inflammatory Bowel Disease, Cellular Therapy and Transplantation (The PREDICT Trial)
PREDICT
1 other identifier
observational
1,000
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
4 active sites
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
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 26, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2032
March 18, 2026
March 1, 2026
12.7 years
September 26, 2017
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
To identify the mechanisms specific for auto-immune and allo-immune GI disorders.
1 year
Perform flow cytometry, TCR deep sequencing and transcriptome analysis on T cells from the peripheral blood in patients diagnosed with GI GVHD, IBD and FGID and patients receiving cellular therapies.
To identify the mechanisms specific for allo- and auto-immune diseases and the consequences of cellular therapy delivery.
1 year
Secondary Outcomes (3)
Perform longitudinal immune analysis on T cells and B cells purified from patients with allo- and auto-immune diseases and those receiving cellular immunotherapies.
1 year
Perform microbiome analysis longitudinally in patients with auto- and allo-immune diseases.
1 year
Perform longitudinal immune analysis on T- and B-cells as well as measurements of serum antibody titers from patients with allo- and auto-immune disorders who receive immunization against COVID-19.
1 year
Eligibility Criteria
HCT, Cellular Therapy and Non-HCT patients undergoing endoscopy (patients with IBD and FGID) will be recruited from participating centers. This prospective banking study will continue to enroll patients undergoing HCT, endoscopy for IBD or FGID, and cellular therapy on an ongoing, long-term basis. Additional enrollment will come from patients receiving SARS-CoV-2 vaccination after HCT, solid organ transplant, active or recent malignancy or autoimmune or rheumatologic diagnoses, including patients who did not meet eligibility criteria for other cohorts. Additional patients who are healthy blood or bone marrow donors and may or may not be related to the patients with immune dysfunction or receiving HCT will also be enrolled in the study to serve as healthy controls.
You 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.
- Weight ≥3 kg
- Patients receiving adoptive cellular therapy
- Patient and/or legal guardian must sign written informed consent
- 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
- Age \>1 years of age
- Weight \>3 kg
- Obtain informed consent
- Patients must be at least 6 years old and weigh \>/= 10 kg.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
Kaminski J, Fleming RA, Alvarez-Calderon F, Winschel MB, McGuckin C, Ho EE, Eng F, Rui X, Keskula P, Cagnin L, Charles J, Zavistaski J, Margossian SP, Kapadia MA, Rottman JB, Lane J, Baumeister SHC, Tkachev V, Shalek AK, Kean LS, Gerdemann U. B-cell-directed CAR T-cell therapy activates CD8+ cytotoxic CARneg bystander T cells in patients and nonhuman primates. Blood. 2024 Jul 4;144(1):46-60. doi: 10.1182/blood.2023022717.
PMID: 38558106DERIVED
Biospecimen
Whole blood Stool Biopsy tissue from endoscopy Cerebrospinal Fluid Bone marrow aspirate Tissue samples from clinical biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie Kean, MD, PhD
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 26, 2017
First Posted
December 12, 2017
Study Start
May 1, 2017
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2032
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available in approximately 3 years and will be available thereafter for a period of 10 years.
- Access Criteria
- CITI and other ethics training, data transfer agreement with study sponsor.
De-identified Genomic data and clinical outcomes will be shared with other researchers.