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

CellMaxLife1 site in 1 country210 target enrollmentNovember 16, 2017

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: CellMaxLife
Enrollment: 210
Locations: 1
Primary Endpoint: 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.
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 16, 2017

End Date

December 31, 2019

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

CellMaxLife

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects need to sign the informed consent form and age is above
•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

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