ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03480659
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Kazakh Research Institute of Oncology/Radiology
Montreal EpiTerapia Inc.
Canada-Kazakhstan EpiTerapia Inc.
Information provided by (Responsible Party):
HKGepitherapeutics

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.


Condition or disease
Breast Cancer Breast Cancer Female

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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 Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
DNA extracted from plasma and PBMC


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer females
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480659


Contacts
Contact: David Cheishvili, PhD +15142601972 david.cheishvilI@epiterapia.com
Contact: Moshe Szyf, PhD moshe.szyf@hkgepitherapeutics.com

Locations
Kazakhstan
Kazakh Institute of Oncology and Radiology Recruiting
Almaty, Kazakhstan
Contact: Madina Orazgaileva    87070375682    madina259@mail.ru   
Sponsors and Collaborators
HKGepitherapeutics
Kazakh Research Institute of Oncology/Radiology
Montreal EpiTerapia Inc.
Canada-Kazakhstan EpiTerapia Inc.

Responsible Party: HKGepitherapeutics
ClinicalTrials.gov Identifier: NCT03480659     History of Changes
Other Study ID Numbers: HKG-KZ-BrCa-101
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases