Clinical trial · Observational
Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis
Circulating Osteocalcin-positive Cells as a Cell-Based Biomarker of Breast Cancer Bone Metastasis Progression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bone metastasis (i.e. cancer cell spreading to bone) is the major clinical problem of advanced breast cancer patients. Bone metastasis is not curable nor preventable. Currently available therapeutic approaches are only palliative. The major hurdle for improving bone metastasis treatment is lack of sensitive diagnostic tools. Diagnosis of bone metastasis is heavily dependent on radiographic imaging of bone destruction that are detectable only when the lesion is significantly large. Accordingly, if bone metastasis can be detected at an earlier time point when bone destruction is minimal or incipient, treatments can be given earlier and the patients can expect better outcomes. We and others previously have found that a subset of bone-forming cells (i.e. circulating osteocalcin-positive cells) exists in the blood stream of the patients with bone diseases (e.g. bone metastasis and inflammation) or active bone formation (e.g. adolescence) in mouse models anf human samples. Extended from this laboratory observation, this clinical study proposes to test the hypothesis that circulating osteocalcin-positive cells are the early biomarker of breast cancer bone metastasis. For this aim, this study will measure circulating osteocalcin-positive cells in the blood samples of breast cancer patient, and examine whether the measure sensitively detects bone metastasis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating Osteocalcin-positive (cOC) cells | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Bone metastasis(+) with low cOC
- description
- Patients who have bone metastasis with low number of circulating osteocalcin-positive (cOC) cells
- interventionNames
- Diagnostic Test: Circulating Osteocalcin-positive (cOC) cells
- label
- Bone metastasis(+) with high cOC
- description
- Patients who have bone metastasis with high number of circulating osteocalcin-positive (cOC) cells
- interventionNames
- Diagnostic Test: Circulating Osteocalcin-positive (cOC) cells
- label
- Bone metastasis(-) with low cOC
- description
- Patients who have metastasis only in extraskeletal sites with low number of circulating osteocalcin-positive (cOC) cells
- interventionNames
- Diagnostic Test: Circulating Osteocalcin-positive (cOC) cells
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDJeong 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. PMID 28029019
- BACKGROUNDEghbali-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. PMID 15888696
- BACKGROUNDGabrilovich 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. PMID 19197294
- BACKGROUNDManavalan 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. PMID 22740707