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

Launched by BOSTON CHILDREN'S HOSPITAL · Dec 5, 2017

Keywords

ClinConnect Summary

Hypotheses:

Hypothesis #1: The Investigators hypothesize that they can define the molecular mechanisms responsible for Inflammatory Bowel Disease (IBD) and gastrointestinal (GI) acute GVHD and differentiate it from other inflammatory disorders by using advanced immunologic analysis including flow cytometry, TCR deep sequencing and transcriptomics.

Hypothesis #2: The Investigators further hypothesize that longitudinal systems-based immunologic analysis will enable the patient-specific determination of the molecular evolution of IBD as well as acute and chronic GVHD as well post-transplant ...

Gender

ALL

Eligibility criteria

• A. Inclusion criteria for HCT patients:
• • 1. Patients must be at least 1 month old and weigh \>/= 3 kg.
• • 2. Patients receiving any allogeneic or autologous hematopoietic stem cell transplantation (bone marrow, peripheral blood, or cord blood transplant).
• • 3. Patients and/or parents or legal guardians must sign a written informed consent.
• B. Inclusion Criteria for Adoptive Cellular Therapy (CT) patients:
• • 1. Weight ≥3 kg
• • 2. Patients receiving adoptive cellular therapy
• • 3. Patient and/or legal guardian must sign written informed consent
• C. Inclusion criteria for Healthy Donor Blood volunteers:
• • 1. Age 18+
• • 2. Participant does not have signs/symptoms of present illness
• • 3. Participant does not have a known disease affecting the immune system
• • 4. Participant is not on any medication/s that suppress immune system
• • 5. Obtain informed consent
• D. Inclusion criteria for HCT Related and Unrelated Donors:
• • 1. Age \>1 years of age
• • 2. Weight \>3 kg
• • 3. Obtain informed consent
• E. Inclusion criteria for IBD \& FGID patients:
• • 1. Patients must be at least 6 years old and weigh \>/= 10 kg.
• • 2. Patients being evaluated for IBD (new diagnosis or follow up of established disease), OR
• • 3. Patients being evaluated for FGID (new diagnosis or follow up of established disease).
• • 4. Obtain informed consent
• F. Inclusion criteria for HCT \& Cell Therapy Household Members:
• • 1. Household member of a patient who is receiving HCT or Cell Therapy and who is participating in the PREDICT study
• • 2. Age \>1 years of age
• • 3. Weight \>3 kg
• • 4. Obtain informed consent