Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02331212|
Recruitment Status : Withdrawn (Logistical Issues)
First Posted : January 6, 2015
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment|
|Breast Carcinoma Metastatic to the Bone Stage IV Breast Cancer||Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis|
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.
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.
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|
|Actual Enrollment :||0 participants|
|Official Title:||Role of Hyaluronic Acid in Cancer Stem Cell Niche|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Ancillary-correlative (role of HAS2+ in CSCs)
Blood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied.
Other: Cytology Specimen Collection Procedure
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
- HAS2 expression, measured by single-cell PCR [ Time Frame: 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.
- CSC marker expression [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331212
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Kounosuke Watabe||Wake Forest University Health Sciences|