Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant
NCT ID: NCT00900406
Last Updated: 2012-11-06
Study Results
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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COMPLETED
190 participants
OBSERVATIONAL
2007-01-31
2010-03-31
Brief Summary
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PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.
Detailed Description
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* To establish a DNA bank from donor and recipient (prior to transplant) peripheral blood for SNP studies.
* To establish a tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples.
* To establish a tissue bank for proteomic studies using donor and recipient blood and urine samples.
* To establish a tissue bank for various studies using biopsy specimens.
* To establish a tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product.
OUTLINE: Peripheral blood samples are collected from donors prior to stem cell mobilization and from patients prior to starting preparative regimen. Samples are studied by single nucleotide polymorphism (SNP) analysis, SNP array, proteomic analysis, gene expression, and other immunological laboratory methods. Blood, urine, and tissue samples are preserved for future studies. Extra skin biopsies and gastrointestinal biopsies are performed at diagnosis of graft-vs-host disease and preserved in a tissue bank for flow cytometric studies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Recipients of stem cells with graft versus host disease
gene expression analysis
blood collection
microarray analysis
Blood collection
polymorphism analysis
Blood collection
proteomic profiling
Blood collection
flow cytometry
Blood collection
immunologic technique
Blood collection
laboratory biomarker analysis
Blood collection
biopsy
Blood collection
Recipients of stem cells at risk of graft versus host disease
gene expression analysis
blood collection
microarray analysis
Blood collection
polymorphism analysis
Blood collection
proteomic profiling
Blood collection
flow cytometry
Blood collection
immunologic technique
Blood collection
laboratory biomarker analysis
Blood collection
biopsy
Blood collection
Donator of stem cells
gene expression analysis
blood collection
microarray analysis
Blood collection
polymorphism analysis
Blood collection
proteomic profiling
Blood collection
flow cytometry
Blood collection
immunologic technique
Blood collection
laboratory biomarker analysis
Blood collection
biopsy
Blood collection
Interventions
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gene expression analysis
blood collection
microarray analysis
Blood collection
polymorphism analysis
Blood collection
proteomic profiling
Blood collection
flow cytometry
Blood collection
immunologic technique
Blood collection
laboratory biomarker analysis
Blood collection
biopsy
Blood collection
Eligibility Criteria
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Inclusion Criteria
* Approved for allogeneic stem cell transplantation
* Sample of the stem cells from donor must meet 1 of the following criteria:
* Total peripheral blood stem cell dose \> 5 X10\^6 CD34+ cells/kg
* Marrow cell dose \> 3 X 10\^8 nucleated cells/kg
PATIENT CHARACTERISTICS:
* Platelet count \> 50,000/mm³ (for patients undergoing endoscopic biopsies)
* INR \< 1.5 (for patients undergoing endoscopic biopsies)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Madan Jagasia, MD
Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant;
Principal Investigators
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Madan Jagasia, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-BMT-0664
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-061215
Identifier Type: -
Identifier Source: secondary_id
VICC BMT 0664
Identifier Type: -
Identifier Source: org_study_id