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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03494803
• Other study ID #: HKG-KZ-PRAD-103
• Status: Withdrawn
• Start date: June 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2023
• Source: HKGepitherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Metastatic
• Prostatic Neoplasms

Locations

Country	Name	City	State
Kazakhstan	Kazakh Institute of Oncology and Radiology	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
HKGepitherapeutics	Kazakh Research Institute of Oncology & Radiology

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months to 1 year