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Clinical Trials/NCT03488706
NCT03488706
Unknown
N/A

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

CellMaxLife1 site in 1 country500 target enrollmentJanuary 17, 2018
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ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
CellMaxLife
Enrollment
500
Locations
1
Primary Endpoint
Circulating tumor cells detection
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 17, 2018
End Date
June 2, 2021
Last Updated
8 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
CellMaxLife
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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