Using the Transcriptome for Early Detection of Graft Versus Host Disease in Allogeneic Bone Marrow Transplantation
OBJECTIVES:
Primary
- Identify detectable changes in the transcriptomic or proteomic expression prior to
clinical manifestations of graft-versus-host disease (GVHD) in blood samples from
at-risk patients who have undergone allogeneic bone marrow transplantation.
Secondary
- Characterize changes in the transcriptome or proteome expression pattern which are
predictive of clinically significant GVHD in these patients.
- Develop reliable tests which enable early intervention for these patients.
OUTLINE: Blood samples are collected prior to and just after typical onset of clinical
graft-vs-host disease (GVHD) on days 1, 7-10, 20-23, 30-33, and 60 after allogeneic bone
marrow transplantation. RNA is quantified and assessed by microarray analysis to identify
changes to transcriptome or proteome expression and markers predictive of the onset of
clinical GVHD. Samples are also stored for future analysis.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Identification of changes in the transcriptome or proteome expression prior to clinical manifestations of graft-versus-host disease (GVHD) in patient blood samples
Once a minimum of 20 patients have been enrolled and clinically are beyond their period of risk of developing acute GVHD, samples from at least 5 patients who have developed acute GVHD are compared to samples from at least 5 patients who have had no detectable clinical GVHD. If no differences are detected, additional patients/samples will be enrolled/analyzed.
Patients beyond period of risk for developing acute GVHD
No
Roberta Adams, MD
Principal Investigator
Mayo Clinic Hospital
United States: Institutional Review Board
CDR0000588925
NCT00898612
March 2008
Name | Location |
---|---|
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |