Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis (COP-BREAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814811
Recruitment Status : Unknown
Verified January 2019 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
National Cancer Center, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment
Breast Neoplasms Bone Metastases Diagnostic Test: Circulating Osteocalcin-positive (cOC) cells

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Circulating Osteocalcin-positive Cells as a Cell-Based Biomarker of Breast Cancer Bone Metastasis Progression
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Bone metastasis(+) with low cOC
Patients who have bone metastasis with low number of circulating osteocalcin-positive (cOC) cells
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: Circulating Osteocalcin-positive (cOC) cells
Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry




Primary Outcome Measures :
  1. 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

  2. Diagnosis of new bone metastasis [ Time Frame: 18 months after enrollment ]
    De novo bone metastasis will be diagnosed using imaging studies


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females are eligible.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Patients in Seoul National University Hospital or Korea University Anam Hospital, Seoul, Korea
  • Residents of the Republic of Korea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814811


Contacts
Layout table for location contacts
Contact: Sun Wook Cho, M.D., Ph.D. +82-2-2072-4761 swchomd@snu.ac.kr
Contact: Young Shin Song, M.D., Ph.D. +82-2-2072-4761 yssongmd@gmail.com

Locations
Layout table for location information
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Kyung Hwa Park, M.D., Ph.D.    +82-2-920-6841    katyoncopark@gmail.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sun Wook Cho, M.D., Ph.D.    +82-2-2072-4761    swchomd@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
National Cancer Center, Korea
Investigators
Layout table for investigator information
Principal Investigator: Sun Wook Cho, M.D., Ph.D. Seoul National University Hospital
Publications:
Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03814811    
Other Study ID Numbers: SNUH-IRB-1706069859
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
Breast Cancer
Bone
Metastasis
Osteoblast
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases