Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03511859

Enrollment

210

Registered

2018-04-30

Start date

2017-11-16

Completion date

2019-12-31

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer. Circulating tumor cells. CTCs. Cell free DNA. cfDNA

Brief summary

Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* All subjects need to sign the informed consent form and age is above 20. * Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI. * Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis

Exclusion criteria

* Not willing to sign the informed consent form * Have been undergone general anesthesia or regional anesthesia in 1 month * Have been diagnosed with any type of cancer and been treated * Have been suffering from autoimmune disorder such as SLE and RA * Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia. * Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection * Diagnosed with myelodysplastic syndrome or myeloproliferative diseases * Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary

Design outcomes

Primary

Measure	Time frame
The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.	3 months

Countries

Taiwan

Contacts

Primary ContactJoy Chang

joy@cellmaxlife.com+886-2-26558455

Outcome results