Study Stopped
Logistical Issues
Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer
Role of Hyaluronic Acid in Cancer Stem Cell Niche
6 other identifiers
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 2, 2018
June 1, 2018
2.3 years
December 23, 2014
June 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (1)
CSC marker expression
Baseline
Study Arms (1)
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.
Interventions
Correlative studies
Eligibility Criteria
Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
You may qualify if:
- 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
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kounosuke Watabe
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2014
First Posted
January 6, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 2, 2018
Record last verified: 2018-06