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Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00898612
First received: May 9, 2009
Last updated: May 22, 2012
Last verified: May 2012
History of Changes

May 9, 2009
May 22, 2012
March 2008
December 2012   (final data collection date for primary outcome measure)
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.
Identification of changes in the transcriptome or proteome expression prior to clinical manifestations of graft-versus-host disease (GVHD) in patient blood samples [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898612 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Characterization of changes in the expression patterns which are predictive of clinically significant GVHD [ Designated as safety issue: No ]
  • Development of reliable tests to predict GVHD in time for early intervention [ Designated as safety issue: No ]
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Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant
Using the Transcriptome for Early Detection of Graft Versus Host Disease in Allogeneic Bone Marrow Transplantation

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.

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
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Non-Probability Sample

Patients undergoing allogeneic bone marrow transplantation at participating institutions.
Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
46
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December 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Any patient undergoing an allogeneic bone marrow transplantation at one of the participating Mayo Clinic sites

PATIENT CHARACTERISTICS:

  • Body weight ≥ 15 kg
  • Not pregnant
  • Not a prisoner

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898612
CDR0000588925, P30CA015083, 878-05, 878-05
Yes
Roberta H. Adams, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Roberta Adams, MD Mayo Clinic Hospital
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP