Detection of Prostate 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: NCT03494803|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : August 6, 2019
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.
|Condition or disease|
|Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Metastatic|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
- DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate 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 prostate cancer or not.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494803
|Contact: David Cheishvili, PhD||+15142601972||david.cheishvilI@epiterapia.com|
|Contact: Moshe Szyf, PhD|
|Kazakh Institute of Oncology and Radiology||Recruiting|
|Contact: Madina Orazgaileva 87070375682 firstname.lastname@example.org|