- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331212
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
Study Overview
Status
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
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Kounosuke Watabe, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stage IV Breast Cancer
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)Active, not recruitingStage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of Colorado, DenverActive, not recruitingStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of California, San FranciscoMerck Sharp & Dohme LLCTerminatedAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8United States
-
Wake Forest University Health SciencesCompletedStage I Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
NSABP Foundation IncCompletedBreast Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIB Breast Cancer | Locally AdvancedUnited States
-
Eske Corporation S.A.CTerminatedBreast Cancer Stage IV | Breast Cancer Stage IIIA | Breast Cancer, Stage IIIBPeru
-
Indiana University School of MedicineBreast Cancer Research FoundationCompletedQuantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer (EPC)Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage IIUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Breast CarcinomaUnited States
Clinical Trials on Laboratory Biomarker Analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States