Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

HKG Epitherapeutics

Status: Terminated

Conditions: Breast Cancer; Breast Cancer Female

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03480659

HKG-KZ-BrCa-101

Details and patient eligibility

About

A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.

Enrollment: 165 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Histological confirmed breast cancer subtypes (DCIS and invasive)

Exclusion criteria

• Pregnant women
• Minors (subjects less than 18 years of age)
• Prisoners
• Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
• Patients having other than one cancer
• Subjects unable to consent for themselves

Trial design

165 participants in 2 patient groups

Breast Cancer

Description:

Early stage luminal A and triple negative breast cancer \[TNBC\] (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) and HER2-negative (HER2-)

Control

Description:

Age matched control females