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Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection

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ClinicalTrials.gov Identifier: NCT02013180
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mustafa Zafer Temiz, Bagcilar Training and Research Hospital

Brief Summary:

Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the prostate cancer, its specivity is not sufficient. Several PSA variations were defined in order to increase the specivity of the test, but they aren't much more effective than the PSA alone for detection of disease.

In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat cancer disease.

In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA), zinc/PSA, levels for early detection of the prostate cancer.


Condition or disease
Prostate Cancer Detection

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Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection
Study Start Date : July 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort
prostate cancer
prostate adenocarcinoma in pathologic evaluation
control
benign prostatic diseases in pathologic evaluation



Primary Outcome Measures :
  1. Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases [ Time Frame: measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks ]
    Does the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?


Biospecimen Retention:   Samples Without DNA
serum, prostatic tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with LUTS(lower urinary tract symptomps) and elevated serum PSA levels/suspicious rectal examination who undergone transrectal ultrasonography guided prostate biopsy
Criteria

Inclusion Criteria:

Patients with LUTS and elevated serum PSA levels and/or suspicious rectal examination

Exclusion Criteria:

usage of zinc included drugs, older prostatic operations, older prostatic radiotherapy, older prostatic biopsies, chronic rectal diseases (anal fissure, hemorrhoid, etc..), PIN(prostatic intraepithelial neoplasia) and ASAP(atypical small acinar proliferation) in pathologic evaluation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013180


Locations
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Turkey
Bagcilar Training and Research Hospital-Depertmant of Urology
Istanbul, Bagcilar, Turkey, 34100
Sponsors and Collaborators
Bagcilar Training and Research Hospital

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Responsible Party: Mustafa Zafer Temiz, resident, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02013180     History of Changes
Other Study ID Numbers: Zinc/PSA
First Posted: December 17, 2013    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019
Last Verified: November 2017

Keywords provided by Mustafa Zafer Temiz, Bagcilar Training and Research Hospital:
Prostate cancer, PSA, zinc, zinc/PSA

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases