- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814811
Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis (COP-BREAST)
Circulating Osteocalcin-positive Cells as a Cell-Based Biomarker of Breast Cancer Bone Metastasis Progression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bone is the most common site of breast cancer metastasis, and the skeletal-related events (SRE) of bone metastasis such as pathologic fractures, cord compression, hypercalcemia and severe pain, accounting for poor quality of life in the terminal stage of the afflicted patients. Since previous SREs are the major risk factors for subsequent SREs related to serious morbidity and mortality, the early detection of bone metastasis prior to clinical symptoms is essential to the better management of breast cancer patients. Currently, diagnosis of bone metastasis is dependent on imaging modalities such as whole-body bone scintigraphy (WBBS). However, detectability of radionuclide activity in the WBBS depends on gross structural bone destruction resulting from considerable progression of macro-metastasis.
Circulating osteoprogenitor cells that is defined a small monocytic cells expressing osteocalcin, a late osteoblast differentiation marker, had been identified in human peripheral blood mononuclear cells (PBMCs). Flow cytometric analyses of the PBMCs using anti-osteocalcin antibody demonstrated that adolescents who are in the period of rapid bone growth showed higher fractions of osteocalcin-positive cells than adults. Moreover, these cells also positively correlated with pathologic changes of bone turnover in such conditions as fracture, hypoparathyroidism, or diabetes. Collectively, circulating osteoprogenitor cells reflects changes of bone turnover in either physiologic or pathologic status.
The scientific hypothesis of this study is that circulating osteoprogenitor cells increases in the early phase of bone micro-metastasis, and the aim of this clinical study is to investigate the difference of circulating osteoprogenitor cells in metastatic breast cancer with or without bone metastasis. This study will also examine whether the patients who have higher number of osteocalcin-positive cells develop bone metastasis at an earlier time point, to validate the value of circulating osteoprogenitor cells in monitoring and/or predictinng the progression of bone metastasis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sun Wook Cho, M.D., Ph.D.
- Phone Number: +82-2-2072-4761
- Email: swchomd@snu.ac.kr
Study Contact Backup
- Name: Young Shin Song, M.D., Ph.D.
- Phone Number: +82-2-2072-4761
- Email: yssongmd@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Sun Wook Cho, M.D., Ph.D.
- Phone Number: +82-2-2072-4761
- Email: swchomd@snu.ac.kr
-
Seoul, Korea, Republic of, 02841
- Recruiting
- Korea University Anam Hospital
-
Contact:
- Kyung Hwa Park, M.D., Ph.D.
- Phone Number: +82-2-920-6841
- Email: katyoncopark@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Patients in Seoul National University Hospital or Korea University Anam Hospital, Seoul, Korea
- Residents of the Republic of Korea
Description
Inclusion Criteria:
- Stages 2A-4 breast cancer patients who are subject to adjuvant chemotherapy or radiotherapy
- 20 years of age or greater
- Female
- Ability to understand the study objectives and willingness to sign written consent
- ECOG status 0, 1 or 2
Exclusion Criteria:
- History of primary cancer diagnosis in other sites than breast within 5 years
- Diseases of bone metabolism including primary hyperparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta
- ECOG status 3 or 4
- Retraction of written consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bone metastasis(+) with low cOC
Patients who have bone metastasis with low number of circulating osteocalcin-positive (cOC) cells
|
Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry
|
Bone metastasis(+) with high cOC
Patients who have bone metastasis with high number of circulating osteocalcin-positive (cOC) cells
|
Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry
|
Bone metastasis(-) with low cOC
Patients who have metastasis only in extraskeletal sites with low number of circulating osteocalcin-positive (cOC) cells
|
Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry
|
Bone metastasis(-) with high cOC
Patients who have metastasis only in extraskeletal sites with high number of circulating osteocalcin-positive (cOC) cells
|
Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of bone metastasis
Time Frame: 18 months after enrollment
|
Metastatic bone lesions will be re-evaluated at 18 months using imaging studies such as bone scan, CT, MRI, or PET or incidence of active skeletal-related events (SREs) such as pathologic fracture or progressive neurologic signs
|
18 months after enrollment
|
Diagnosis of new bone metastasis
Time Frame: 18 months after enrollment
|
De novo bone metastasis will be diagnosed using imaging studies
|
18 months after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sun Wook Cho, M.D., Ph.D., Seoul National University Hospital
Publications and helpful links
General Publications
- Jeong HM, Cho SW, Park SI. Osteoblasts Are the Centerpiece of the Metastatic Bone Microenvironment. Endocrinol Metab (Seoul). 2016 Dec;31(4):485-492. doi: 10.3803/EnM.2016.31.4.485.
- Eghbali-Fatourechi GZ, Lamsam J, Fraser D, Nagel D, Riggs BL, Khosla S. Circulating osteoblast-lineage cells in humans. N Engl J Med. 2005 May 12;352(19):1959-66. doi: 10.1056/NEJMoa044264.
- Gabrilovich DI, Nagaraj S. Myeloid-derived suppressor cells as regulators of the immune system. Nat Rev Immunol. 2009 Mar;9(3):162-74. doi: 10.1038/nri2506.
- Manavalan JS, Cremers S, Dempster DW, Zhou H, Dworakowski E, Kode A, Kousteni S, Rubin MR. Circulating osteogenic precursor cells in type 2 diabetes mellitus. J Clin Endocrinol Metab. 2012 Sep;97(9):3240-50. doi: 10.1210/jc.2012-1546. Epub 2012 Jun 27.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUH-IRB-1706069859
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Breast Neoplasms
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Emory UniversityEisai Inc.TerminatedBreast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, BreastUnited States
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
Providence Health & ServicesBrooklyn ImmunoTherapeutics, LLCActive, not recruitingBreast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, MaleUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
BerGenBio ASAMerck Sharp & Dohme LLCTerminatedTriple Negative Breast Cancer | Inflammatory Breast Cancer Stage IVSpain, United States, United Kingdom, Norway
-
CytomX TherapeuticsCompletedNeoplasms | Breast Cancer | Breast Neoplasms | Breast Neoplasms, Triple-Negative | Breast Neoplasms, Hormone Receptor Positive/HER2 NegativeUnited States, Spain, Korea, Republic of
-
Dana-Farber Cancer InstituteConquer Cancer FoundationRecruitingBreast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Inflammatory Breast Cancer | Hormone Receptor Positive Malignant Neoplasm of BreastUnited States
Clinical Trials on Circulating Osteocalcin-positive (cOC) cells
-
Zhujiang HospitalNot yet recruitingRecurrence | Hepatocellular Carcinoma | Surgery | Circulating Tumor CellChina
-
Institut de Cancérologie de LorraineCompleted
-
Beijing Viroad Biotechnology Co., Ltd.UnknownCirculating Tumor Cells.BreastChina
-
AC Camargo Cancer CenterInternational Atomic Energy AgencyCompletedBreast Cancer | Brain CancerBrazil
-
Menarini Silicon Biosystems, INCMedex15RecruitingMetastatic Breast CancerUnited States
-
Centre Hospitalier Universitaire de NīmesActive, not recruitingAdenocarcinoma of the ProstateFrance
-
Beijing 302 HospitalRecruiting
-
Beijing 302 HospitalRecruiting
-
Anhui Medical UniversityTechnion, Israel Institute of TechnologyUnknownBreast Cancer | Gastric Cancer | Diagnoses Disease | Circulating Tumor Cell | Volatile Organic Chemicals
-
Sun Yat-sen UniversityCompletedNasopharyngeal Neoplasms