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

Withdrawn

• Conditions: Breast Carcinoma Metastatic to the Bone; Stage IV Breast Cancer
• Interventions: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02331212
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Study Start: 2015-03
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (role of HAS2+ in CSCs)	Cytology Specimen Collection Procedure	Blood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied.
Ancillary-correlative (role of HAS2+ in CSCs)	Laboratory Biomarker Analysis	Blood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied.

Primary Outcome Measures

Name	Time	Method
HAS2 expression, measured by single-cell PCR	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
CSC marker expression	Baseline	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States