Status:
ENROLLING_BY_INVITATION
Precision Diagnostics in Inflammatory Bowel Disease, Cellular Therapy and Transplantation (The PREDICT Trial)
Lead Sponsor:
Boston Children's Hospital
Conditions:
Graft Vs Host Disease
Inflammatory Bowel Diseases
Eligibility:
All Genders
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 th...
Detailed Description
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 differ...
Eligibility Criteria
Inclusion
- A. Inclusion criteria for HCT patients:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03369353
Start Date
May 1 2017
End Date
January 1 2030
Last Update
August 20 2024
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105