Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer

Wake Forest University Health Sciences

Overview

This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.

PRIMARY OBJECTIVES: I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease. SECONDARY OBJECTIVES: I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation \[CD\]24-/CD44+/epithelial specific antigen \[ESA\]+) cells will have the most aggressive growth in the bone, using an animal model. OUTLINE: Blood and bone marrow samples are collected and analyzed via flow cytometry and polymerase chain reaction (PCR). Cells are also transplanted into mice and studied.

Study Type

OBSERVATIONAL

Conditions

Breast Carcinoma Metastatic to the Bone Stage IV Breast Cancer

Interventions

Cytology Specimen Collection ProcedureOTHER

Correlative studies

Laboratory Biomarker AnalysisOTHER

Correlative studies

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have newly diagnosed, histologically confirmed primary and/or metastatic breast cancer * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

HAS2 expression, measured by single-cell PCR

Descriptive statistics will be generated. The relationship of each cell's bone metastatic ability and HAS2 expression will be examined using correlations within each group between these two measures. The mean values of the HAS2 expression and bone metastatic ability will be compared between groups using one-way analysis of variance (ANOVA) models. In addition, 2-sample t-tests will be used to compare the primary cancer and bone metastases groups.

Time frame: Baseline

Secondary Outcomes

CSC marker expression

Expression of CSC markers including CD24, CD44 and ESA will be examined. These will also be examined using descriptive statistics and compared with each other using one-way ANOVA models and 2-sample t-tests to compare the primary cancer and bone metastases groups.

Time frame: Baseline

Data from ClinicalTrials.gov

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