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NCT Number: NCT00900406

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Cardiovascular Diseases Chronic Myeloproliferative Disorders Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pregnancy Complications Pregnancy Complications, Neoplastic Skin Diseases Skin and Connective Tissue Diseases Testicular Germ Cell Tumor Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

blood collection

microarray analysis

Genetic

Blood collection

polymorphism analysis

Genetic

Blood collection

proteomic profiling

Genetic

Blood collection

flow cytometry

Other

Blood collection

immunologic technique

Other

Blood collection

laboratory biomarker analysis

Other

Blood collection

Biopsy

Procedure

Blood collection

Primary outcomes

  1. DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies

    Time frame: Completion of transplant

  2. Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples

    Time frame: End of treatment

  3. Tissue bank for proteomic studies using donor and recipient blood and urine samples

    Time frame: End of treatment

  4. Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product

    Time frame: End of treatment

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 12, 2009
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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