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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900406
Enrollment
190
Registered
2009-05-12
Start date
2007-01-31
Completion date
2010-03-31
Last updated
2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

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.

Interventions

GENETICgene expression analysis

blood collection

GENETICmicroarray analysis

Blood collection

GENETICpolymorphism analysis

Blood collection

GENETICproteomic profiling

Blood collection

OTHERflow cytometry

Blood collection

OTHERimmunologic technique

Blood collection

OTHERlaboratory biomarker analysis

Blood collection

PROCEDUREbiopsy

Blood collection

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studiesCompletion of transplant
Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samplesEnd of treatment
Tissue bank for proteomic studies using donor and recipient blood and urine samplesEnd of treatment
Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell productEnd of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026