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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
Sponsor:
Collaborators:
Kazakh Research Institute of Oncology & Radiology
Montreal EpiTerapia Inc.
Canada-Kazakhstan EpiTerapia Inc.
Kazakhstan-Canada Research Center of Genetics and Epitherapy
Information provided by (Responsible Party):
HKGepitherapeutics

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.


Condition or disease
Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Metastatic

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
Control
Prostate Cancer



Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494803


Contacts
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Contact: David Cheishvili, PhD +15142601972 david.cheishvilI@epiterapia.com
Contact: Moshe Szyf, PhD

Locations
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Kazakhstan
Kazakh Institute of Oncology and Radiology Recruiting
Almaty, Kazakhstan
Contact: Madina Orazgaileva    87070375682    madina259@mail.ru   
Sponsors and Collaborators
HKGepitherapeutics
Kazakh Research Institute of Oncology & Radiology
Montreal EpiTerapia Inc.
Canada-Kazakhstan EpiTerapia Inc.
Kazakhstan-Canada Research Center of Genetics and Epitherapy

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Responsible Party: HKGepitherapeutics
ClinicalTrials.gov Identifier: NCT03494803     History of Changes
Other Study ID Numbers: HKG-KZ-PRAD-103
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type