Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/1/2019 |
| Start Date: | January 2014 |
| End Date: | June 2019 |
This study is designed to collect longitudinal biological samples from patients after
hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers
to validate biomarkers of both acute and chronic GVHD as well as for use in future
unspecified research. The centers include Dana-Farber Cancer Institute and Boston's
Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson
Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and
Indiana University Simon Cancer Center.
hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers
to validate biomarkers of both acute and chronic GVHD as well as for use in future
unspecified research. The centers include Dana-Farber Cancer Institute and Boston's
Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson
Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and
Indiana University Simon Cancer Center.
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:
1. 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.
2. 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).
3. 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.
4. To develop a repository of biospecimens linked to clinical data for future unspecified
research.
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:
1. 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.
2. 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).
3. 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.
4. To develop a repository of biospecimens linked to clinical data for future unspecified
research.
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.
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