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

March 6, 2014 updated by: Mayo Clinic

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing allogeneic bone marrow transplantation at participating institutions.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Patient beyond period of risk for developing acute GVHD
Development of reliable tests to predict GVHD in time for early intervention
Time Frame: Patient beyond period of risk for developing acute GVHD
Patient beyond period of risk for developing acute GVHD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roberta Adams, MD, Mayo Clinic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000588925
  • P30CA015083 (U.S. NIH Grant/Contract)
  • 878-05 (Other Identifier: Mayo Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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