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

• Conditions: Graft Vs Host Disease; Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders

• Registration Number: NCT03369353
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-9-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;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.

Secondary Outcome Measures

Name	Time	Method
Perform longitudinal immune analysis on T cells and B cells purified from patients with allo- and auto-immune diseases and those receiving cellular immunotherapies.;Perform microbiome analysis longitudinally in patients with auto- and allo-immune diseases.;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.