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Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900406
First Posted: May 12, 2009
Last Update Posted: November 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
  Purpose

RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients undergoing a donor stem cell transplant to test in the laboratory may help the study of graft-versus-host disease in the future.

PURPOSE: This research study is collecting and storing tissue and DNA samples from patients undergoing a donor stem cell transplant.


Condition Intervention
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Genetic: proteomic profiling Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)

Resource links provided by NLM:


Further study details as provided by Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies [ Time Frame: Completion of transplant ]
  • Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples [ Time Frame: End of treatment ]
  • Tissue bank for proteomic studies using donor and recipient blood and urine samples [ Time Frame: End of treatment ]
  • Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product [ Time Frame: End of treatment ]

Biospecimen Retention:   Samples Without DNA
Blood collection

Enrollment: 190
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Recipients of stem cells with graft versus host disease Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection
Recipients of stem cells at risk of graft versus host disease Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection
Donator of stem cells Genetic: gene expression analysis
blood collection
Genetic: microarray analysis
Blood collection
Genetic: polymorphism analysis
Blood collection
Genetic: proteomic profiling
Blood collection
Other: flow cytometry
Blood collection
Other: immunologic technique
Blood collection
Other: laboratory biomarker analysis
Blood collection
Procedure: biopsy
Blood collection

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People who have received a stem cell transplant and are being treated for graft versus host disease or are at risk of graft versus host disease.
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900406


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Madan Jagasia, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Madan Jagasia, MD, Associate Professor of Medicine; Director, Outpatient Transplant Program; Section Chief, Hematology and Stem Cell Transplant;, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00900406     History of Changes
Other Study ID Numbers: VICC BMT 0664
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BMT-0664
VU-VICC-IRB-061215
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: November 6, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Graft vs Host Disease
Myeloproliferative Disorders
Neoplasms, Plasma Cell
Plasmacytoma
Testicular Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial