Prostate CancerNCT03494803
Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by HKGepitherapeutics at 1 site in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Metastatic
- How many people
- 0 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Jun 2018to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Adult, Older adult
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
Who may be able to join
- Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| Prostate Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: No participants enrolled, leading to insufficient patient numbers to initiate the clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HKGepitherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kazakh Research Institute of Oncology & Radiology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494803
- Sponsor's protocol ID
- HKG-KZ-PRAD-103
- Status last verified
- Dec 2023
- First submitted
- 4 Apr 2018
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03494803
- Acronym / sponsor ID
- HKG-KZ-PRAD-103
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled, leading to insufficient patient numbers to initiate the clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HKGepitherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Kazakh Research Institute of Oncology & Radiology
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| Prostate Cancer | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff
Key exclusion criteria (6 listed)
- Pregnant women
- Minors (subjects less than 18 years of age)
- Prisoners
- Patients having other than one cancer
- Subjects unable to consent for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by HKGepitherapeutics at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.