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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Breast Cancer Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast Cancer

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

No interventions assigned to this group

Control

Age matched control females

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kazakh Institute of Oncology and Radiology

Almaty, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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HKG-KZ-BrCa-101

Identifier Type: -

Identifier Source: org_study_id