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

Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03494803
Enrollment
0
Registered
2018-04-11
Start date
2018-06-01
Completion date
2021-12-01
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma, Prostate Cancer, Prostate Cancer Metastatic

Brief 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.

Interventions

None listed

Sponsors

Kazakh Research Institute of Oncology & Radiology
CollaboratorOTHER
HKGepitherapeutics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frameDescription
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer6 months to 1 yearWe 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.

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026