Breast Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

190

Study ID:

NCT00900406

Recruitment Status:

Completed

Sponsor:

Vanderbilt-Ingram Cancer Center

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There are 2 Locations for this study

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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

190

Study ID:

NCT00900406

Recruitment Status:

Completed

Sponsor:


Vanderbilt-Ingram Cancer Center

How clear is this clinincal trial information?

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