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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03488706
Other study ID # CMx-CTC-PC-001
Secondary ID
Status Recruiting
Phase
First received March 29, 2018
Last updated March 29, 2018
Start date January 17, 2018
Est. completion date June 2, 2021

Study information

Verified date March 2018
Source CellMaxLife
Contact Joy Chang
Phone +886-2-26558455
Email joy@cellmaxlife.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 potential to substantially decrease the number of unnecessary prostate biopsies.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 2, 2021
Est. primary completion date December 12, 2018
Accepts healthy volunteers
Gender Male
Age group 20 Years to 99 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Diagnosed with colorectal polyps or adenomas

- Acute inflammatory or infectious diseases in three months

- Other diseases decided by PI

Study Design


Locations

Country Name City State
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
CellMaxLife

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circulating tumor cells detection Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level Prior to prostate biopsy
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