Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

NCT ID: NCT03488706

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-17

Study Completion Date

2021-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gray Zone Group

The gray zone group PSA between 4.00 to 10.99 ng/ml.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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CellMaxLife

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying-Hsu Chang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Joy Chang

Role: CONTACT

+886-2-26558455 ext. 404

Facility Contacts

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Ying-Hsu Chang

Role: primary

Other Identifiers

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CMx-CTC-PC-001

Identifier Type: -

Identifier Source: org_study_id

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