Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer
June 29, 2018 updated by: Wake Forest University Health Sciences
Role of Hyaluronic Acid in Cancer Stem Cell Niche
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Correlative studies
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kounosuke Watabe, Wake Forest University Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
December 23, 2014
First Submitted That Met QC Criteria
January 2, 2015
First Posted (Estimate)
January 6, 2015
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 29, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00030529
- P30CA012197 (U.S. NIH Grant/Contract)
- NCI-2014-02554 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 74A14
- CCCWFU 74A14 (Other Identifier: Wake Forest University Health Sciences)
- R01CA173499 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.