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

NCT ID: NCT00898612

Last Updated: 2014-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic Cancer Center

Principal Investigators

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Roberta Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Hospital

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

878-05

Identifier Type: OTHER

Identifier Source: secondary_id

878-05

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000588925

Identifier Type: -

Identifier Source: org_study_id

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