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

CellMaxLife210 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Central Contacts

Joy Chang

CONTACT

+886-2-26558455 joy@cellmaxlife.com

Data from ClinicalTrials.gov

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