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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00900406
First received: May 9, 2009
Last updated: November 4, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
  • Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Tissue bank for proteomic studies using donor and recipient blood and urine samples [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, VU-VICC-BMT-0664, VU-VICC-IRB-061215
Study First Received: May 9, 2009
Last Updated: November 4, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Graft vs Host Disease
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neuroblastoma
Ovarian Neoplasms
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
 Gestational Trophoblastic Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Immune System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders

ClinicalTrials.gov processed this record on May 23, 2013