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

HKGepitherapeutics

Overview

Prostate cancer is a leading cause of mortality and morbidity. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Metastatic

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff Exclusion Criteria: * Pregnant women * Minors (subjects less than 18 years of age) * Prisoners * Patients having other than one cancer * Subjects unable to consent for themselves * Symptomatic of acute prostatitis

Locations (1)

Kazakh Institute of Oncology and Radiology

Almaty, Kazakhstan

Outcomes

Primary Outcomes

DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate 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 prostate cancer or not.

Time frame: 6 months to 1 year

Data from ClinicalTrials.gov

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