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Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis

NCT03814811 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-01-24

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Circulating Osteocalcin-positive (cOC) cells

Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry

Sponsors & Collaborators

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sun Wook Cho, M.D., Ph.D. · Seoul National University Hospital

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-09-30
Completion
2021-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814811 on ClinicalTrials.gov