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

Vanderbilt University Medical Center

Status: Completed

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

Treatments: Procedure: biopsy; Other: immunologic technique; Other: laboratory biomarker analysis; Genetic: proteomic profiling; Genetic: microarray analysis; Other: flow cytometry; Genetic: polymorphism analysis; Genetic: gene expression analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00900406

VU-VICC-IRB-061215

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-BMT-0664

VICC BMT 0664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

190 participants in 3 patient groups

Recipients of stem cells with graft versus host disease

Treatment:

Procedure: biopsy

Other: immunologic technique

Genetic: proteomic profiling

Genetic: microarray analysis

Other: laboratory biomarker analysis

Genetic: polymorphism analysis

Genetic: gene expression analysis

Other: flow cytometry

Recipients of stem cells at risk of graft versus host disease

Treatment:

Procedure: biopsy

Other: immunologic technique

Genetic: proteomic profiling

Genetic: microarray analysis

Other: laboratory biomarker analysis

Genetic: polymorphism analysis

Genetic: gene expression analysis

Other: flow cytometry

Donator of stem cells

Treatment:

Procedure: biopsy

Other: immunologic technique

Genetic: proteomic profiling

Genetic: microarray analysis

Other: laboratory biomarker analysis

Genetic: polymorphism analysis

Genetic: gene expression analysis

Other: flow cytometry