- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194439
Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
Study Overview
Status
Conditions
Detailed Description
After informed consent is signed, this study will involve 1) collection of basic HCT data and clinical data available in the medical record and 2) providing blood (and saliva in occasional cases) samples for processing, storage, DNA extraction, and analysis (including a seven biomarker protein panel as well as future unspecified research purposes).
Pediatric and adult patients will be included (all adult patients will be from the Fred Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and the Indiana University Simon Cancer Center).
Primary Objective:
1. To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response, and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.
Secondary Objective:
- To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21 post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse mortality.
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting with similar symptoms (drug rash, CMV, Clostridium enteritis).
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.
- To develop a repository of biospecimens linked to clinical data for future unspecified research.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana Unversity Melvin and Bren Simon Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: - All patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) can be included.
Exclusion Criteria: - patients not receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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hematopoietic stem cell transplant
procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Time Frame: 1 year
|
To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sophie Paczesny, MD, PhD, Indiana University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Affect
- Biomarkers
- Cells
- Autoimmunity
- Outcome
- Allogeneic
- Response
- Genomics
- Cytokine
- Proteomics
- Development
- Environment
- Immune Response
- HCT
- Hematopoietic
- Acute Graft Versus Host Disease
- Anti-inflammatory
- Anti-inflammatory Agents
- Antigen-Presenting Cells
- Alloantigen
- Allograft rejection
- Allograft Tolerance
- Antigens
- Biospecimen Repository
- BMT
- Bone Marrow Transplantation
- Cell Transplantation
- Clonal Expansion
- Complex
- Data
- Failure (biologic function)
- Graft-vs-Host Disease
- Graft-vs-Leukemia
- GVHD
- GVL
- Hematopoietic Stem Cell Transplantation
- HSCT
- IL-33 Receptor
- Immune Reconstitution
- Inflammatory
- Modeling
- Novel
- Novel therapeutics
- Pathway interactions
- Peptides
- Prevent
- Process
- Production
- Regulatory T-Lymphocyte
- Role
- Signal
- ST2
- Transduction
- T-cell response
- T-cell Activation
- T-Lymphocytes
- Tissues
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1405976232
- 1R01HD074587-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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