Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant
RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a donor bone marrow transplant may help doctors learn more about changes that occur in DNA and identify biomarkers related to graft-versus-host disease. It may also help doctors predict how patients will respond to a donor bone marrow transplant.
PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in patients undergoing a donor bone marrow transplant.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Using the Transcriptome for Early Detection of Graft Versus Host Disease in Allogeneic Bone Marrow Transplantation|
- Identification of changes in the transcriptome or proteome expression prior to clinical manifestations of graft-versus-host disease (GVHD) in patient blood samples [ Time Frame: Patients beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]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.
- Characterization of changes in the expression patterns which are predictive of clinically significant GVHD [ Time Frame: Patient beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]
- Development of reliable tests to predict GVHD in time for early intervention [ Time Frame: Patient beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898612
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|Principal Investigator:||Roberta Adams, MD||Mayo Clinic Hospital|