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

Breast Cancer Clinical Trial

Official title:

Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03480659
• Other study ID #: HKG-KZ-BrCa-101
• Status: Terminated
• Start date: June 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2023
• Source: HKGepitherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: September 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms

Locations

Country	Name	City	State
Kazakhstan	Kazakh Institute of Oncology and Radiology	Almaty

Sponsors (4)

Lead Sponsor	Collaborator
HKGepitherapeutics	Canada-Kazakhstan EpiTerapia Inc., Kazakh Research Institute of Oncology & Radiology, Montreal EpiTerapia Inc.

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer	We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers: Methylation score=CG1*b1+CG2*b2+ CG3*b3 + e; CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept.; We will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as breast cancer or not.	6 months to 1 year