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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900406
• Other study ID #: VICC BMT 0664
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 4, 2012
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: November 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Genetic:
• gene expression analysis
blood collection
• microarray analysis
Blood collection
• polymorphism analysis
Blood collection
• proteomic profiling
Blood collection

Other:
• flow cytometry
Blood collection
• immunologic technique
Blood collection
• laboratory biomarker analysis
Blood collection

Procedure:
• biopsy
Blood collection

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA bank from donor and recipient (prior to transplant) peripheral blood for single nucleotide polymorphism studies		Completion of transplant	No
Primary	Tissue bank for gene expression studies using donor and recipient (post-transplant) peripheral blood samples		End of treatment	No
Primary	Tissue bank for proteomic studies using donor and recipient blood and urine samples		End of treatment	No
Primary	Tissue bank for flow cytometric studies using recipient (post-transplant), and sample from stem cell product		End of treatment	No