Breast Carcinoma Metastatic to the BoneNCT02331212
Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer
An observational study of Breast Carcinoma Metastatic to the Bone and Stage IV Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Carcinoma Metastatic to the Bone, Stage IV Breast Cancer
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
Who may be able to join
- 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
Who cannot join
- Patients who have had chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Correlative studies
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
CSC marker expression
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Logistical Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Carcinoma Metastatic to the BoneStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kounosuke Watabe, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331212
- Sponsor's protocol ID
- IRB00030529
- Other IDs
- NCI-2014-02554, 74A14, CCCWFU 74A14, CCCWFU 74A14, R01CA173499, P30CA012197
- Status last verified
- Jun 2018
- First submitted
- 23 Dec 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hyaluronic Acid in Cancer Stem Cell Niche
- ClinicalTrials.gov ID
- NCT02331212
- Acronym / sponsor ID
- IRB00030529
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (role of HAS2+ in CSCs) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisBlood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have had chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingCorrelative studies | Other | Ancillary-correlative (role of HAS2+ in CSCs) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-correlative (role of HAS2+ in CSCs) |
Primary outcome
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.
1 secondary outcome
CSC marker expression
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kounosuke Watabe principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma Metastatic to the Bone and Stage IV Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAS2 expression, measured by single-cell PCR (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.