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

Withdrawn

• Conditions: Lymphoma

• Registration Number: NCT00898612
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of changes in the transcriptome or proteome expression prior to clinical manifestations of graft-versus-host disease (GVHD) in patient blood samples	Patients beyond period of risk for developing acute GVHD	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.

Secondary Outcome Measures

Name	Time	Method
Characterization of changes in the expression patterns which are predictive of clinically significant GVHD	Patient beyond period of risk for developing acute GVHD
Development of reliable tests to predict GVHD in time for early intervention	Patient beyond period of risk for developing acute GVHD

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States