---
title: Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
nct_id: NCT03480659
overall_status: TERMINATED
sponsor: HKGepitherapeutics
study_type: OBSERVATIONAL
primary_condition: Breast Cancer
countries: Kazakhstan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03480659.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03480659"
ct_last_update_post_date: 2023-12-21
last_seen_at: "2026-05-12T06:12:19.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

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

**NCT ID:** [NCT03480659](https://clinicaltrials.gov/study/NCT03480659)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Experienced technical issues with plasma blood samples collected from patients.
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 165
- **Lead Sponsor:** HKGepitherapeutics
- **Collaborators:** Kazakh Research Institute of Oncology & Radiology, Montreal EpiTerapia Inc., Canada-Kazakhstan EpiTerapia Inc.
- **Conditions:** Breast Cancer, Breast Cancer Female
- **Start Date:** 2018-06-01
- **Completion Date:** 2021-09-01
- **CT.gov Last Update:** 2023-12-21

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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

## Primary Outcomes

- **DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer** _(time frame: 6 months to 1 year)_ — 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.

## Locations (1)

- Kazakh Institute of Oncology and Radiology, Almaty, Kazakhstan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kazakh institute of oncology and radiology|almaty||kazakhstan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03480659.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03480659*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*