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

Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Myelodysplastic Syndromes; Leukemia; Testicular Germ Cell Tumor; Breast Cancer; Chronic Myeloproliferative Disorders; Ovarian Cancer; Gestational Trophoblastic Tumor; Neuroblastoma; Multiple Myeloma and Plasma Cell Neoplasm; Graft Versus Host Disease; Myelodysplastic/Myeloproliferative Neoplasms
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center - Cool Springs
    • Nashville, Tennessee, United States, 37064
      • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

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): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 4, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Glandular and Epithelial; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Pregnancy Complications; Neuroectodermal Tumors, Primitive; Pregnancy Complications, Neoplastic; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms; Myelodysplastic Syndromes; Multiple Myeloma; Neoplasms, Plasma Cell; Trophoblastic Neoplasms; Neuroblastoma; Plasmacytoma; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease
• Other Study ID Numbers: VICC BMT 0664; P30CA068485 (U.S. NIH Grant/Contract); VU-VICC-BMT-0664; VU-VICC-IRB-061215