Clinical trial NCT00900406: Collecting and Storing Tissue and DNA Samples From Patients Undergoing a Donor Stem Cell Transplant
Official title: Tissue Bank for Studies Related to Graft-Versus-Host Disease (GVHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies
timeFrame: Completion of transplant
measure: Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples
timeFrame: End of treatment
measure: Tissue bank for proteomic studies using donor and recipient blood and urine samples
timeFrame: End of treatment
measure: Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product
timeFrame: End of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Madan Jagasia, MD
role: STUDY_CHAIR
References: