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

NCT03480659 | Terminated

• 1 other identifier: HKG-KZ-BrCa-101
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Breast Cancer

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

Control

Age matched control females

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Breast cancer females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of Breast cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form

You may qualify if:

• Histological confirmed breast cancer subtypes (DCIS and invasive)

You may not qualify if:

• 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

Sponsors & Collaborators

• HKGepitherapeutics: lead
• Kazakh Research Institute of Oncology & Radiology: collaborator
• Montreal EpiTerapia Inc.: collaborator
• Canada-Kazakhstan EpiTerapia Inc.: collaborator

Study Sites (1)

Kazakh Institute of Oncology and Radiology

Almaty, Kazakhstan

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from plasma and PBMC

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

KA (1)