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

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Breast Carcinoma Metastatic to the Bone

Stage IV Breast Cancer

Treatments

Other: Cytology Specimen Collection Procedure

Other: Laboratory Biomarker Analysis

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02331212

CCCWFU 74A14

IRB00030529

P30CA012197 (U.S. NIH Grant/Contract)

74A14

R01CA173499 (U.S. NIH Grant/Contract)

NCI-2014-02554 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex

Female

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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