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

NCT03494803 | Withdrawn

• 1 other identifier: HKG-KZ-PRAD-103
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: 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 Prostate 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

You may qualify if:

• Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff

You may not qualify if:

• 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

Sponsors & Collaborators

• HKGepitherapeutics: lead
• Kazakh Research Institute of Oncology & Radiology: collaborator

Study Sites (1)

Kazakh Institute of Oncology and Radiology

Almaty, Kazakhstan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

KA (1)