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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511859
• Other study ID #: CMx-CTC-BC-001
• Status: Recruiting
• Start date: November 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2018
• Source: CellMaxLife
• Contact: Joy Chang
• Phone: +886-2-26558455
• Email: joy[@]cellmaxlife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
CellMaxLife

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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