Prostate CancerNCT03488706
Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
An observational study of Prostate Cancer, run by CellMaxLife at 1 site in Taiwan.
Trial summary
Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified… Read more about this study
- Who is it for?
- Ages 20 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2018to 2 Jun 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 20 to 99 years
- Men only
- Adult, Older adult
Study population: PSA 4.00- 10.99 ng/ml patients
Who may be able to join
- Subjects are willing to sign the informed consent and agree to comply with the study procedures.
- Age from 20 to 99 years old
- Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months
Who cannot join
- Age < 20 years
- Refuse to sign the informed consent form
- Received regional anesthesia and general anesthesia within one month
- Previous cancer history
- Autoimmune diseases
- Chronic inflammatory diseases
Show all 9Show fewer
- Diagnosed with colorectal polyps or adenomas
- Acute inflammatory or infectious diseases in three months
- Other diseases decided by PI
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City
Ying-Hsu Chang
About this study
Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.
- Conditions
- Prostate Cancer
- 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 |
|---|---|---|
| Gray Zone Group | The gray zone group PSA between 4.00 to 10.99 ng/ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cells detection
Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level
Measured: Prior to prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start17 Jan 2018
- Primary completion12 Dec 2018 (estimated)
- Study completion2 Jun 2021 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellMaxLife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying-Hsu Chang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488706
- Sponsor's protocol ID
- CMx-CTC-PC-001
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
- ClinicalTrials.gov ID
- NCT03488706
- Acronym / sponsor ID
- CMx-CTC-PC-001
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CellMaxLifeIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 12 Dec 2018 (estimated)
- Study completion
- 2 Jun 2021 (estimated)
- First posted
- 5 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 screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gray Zone Group | – | –The gray zone group PSA between 4.00 to 10.99 ng/ml. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- PSA 4.00- 10.99 ng/ml patients
Key inclusion criteria (3 listed)
- Subjects are willing to sign the informed consent and agree to comply with the study procedures.
- Age from 20 to 99 years old
- Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months
Key exclusion criteria (9 listed)
- Age < 20 years
- Refuse to sign the informed consent form
- Received regional anesthesia and general anesthesia within one month
- Previous cancer history
- Autoimmune diseases
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
Circulating tumor cells detection
Time frame: Prior to prostate biopsy
Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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.
Ying-Hsu Chang principal investigator
Chang Gung Memorial Hospital
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, run by CellMaxLife at 1 site in Taiwan.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joy Chang (+886-2-26558455 ext. 404, joy@cellmaxlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cells detection (time frame: Prior to prostate biopsy). 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 5 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.