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

CellMax Life

Status

Unknown

Conditions

Breast Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT03511859

CMx-CTC-BC-001

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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