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Changing of Prostate Specific Antigen Value in Patients With Covid-19

Primary Purpose

Covid19, Prostate Specific Antigen

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

PSA value

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring Covid-19, Prostate cancer, Prostate Specific Antigen

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients (>45 and <70 years of age) positive PCR test results were included in the study

Exclusion Criteria:

The patients <45 and >70 years of age who described lower urinary tract symptoms who had urinary tract infection who a history of prostate biopsy and previous high level of PSA who history of prostatitis were excluded.

Sites / Locations

Omer Gokhan DoluogluRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Covid-19 group

Arm Description

We will measure the PSA value during and after Covid-19 infection in the same group via paired simple t test

Outcomes

Primary Outcome Measures

PSA value

prostate specific antigen

Secondary Outcome Measures

Ferritin, CRP

Full Information

NCT ID

NCT05009186

First Posted

August 15, 2021

Last Updated

August 15, 2021

Sponsor

Saglik Bilimleri Universitesi

1. Study Identification

Unique Protocol Identification Number

NCT05009186

Brief Title

Changing of Prostate Specific Antigen Value in Patients With Covid-19

Official Title

Changing of PSA With Covid-19

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

October 1, 2021 (Anticipated)

Study Completion Date

October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a worldwide pandemic in over 100 years. The disease caused by this newly discovered virus was called Covid-19. In this study, we aimed to evaluate changing of PSA value in patients with Covid-19.

Detailed Description

Patients with positive PCR test results were included in the study. The age of the patient and urea, leukocyte, hemoglobin, platelet, urea, and creatinine values of the patients were recorded. Urinalysis and urine culture were taken from all patients. Acute phase reactants such as sedimentation, C-reaktif protein (CRP), ferritin, and fibrinogen were measured both at the time the patients applied and three weeks after the patient recovered. PSA and free PSA were also measured in the same way. Patients whose symptoms improved and the PCR test result was negative were considered as recovered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Prostate Specific Antigen

Keywords

Covid-19, Prostate cancer, Prostate Specific Antigen

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

We measured PSA value during and after Covid-19 infection

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Covid-19 group

Arm Type

Other

Arm Description

We will measure the PSA value during and after Covid-19 infection in the same group via paired simple t test

Intervention Type

Other

Intervention Name(s)

PSA value

Intervention Description

We measure PSA value during and after covid-19 infection

Primary Outcome Measure Information:

Title

PSA value

Description

prostate specific antigen

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Ferritin, CRP

Time Frame

2 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

The male patients >45 and <70 years of age included to the study

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients (>45 and <70 years of age) positive PCR test results were included in the study Exclusion Criteria: The patients <45 and >70 years of age who described lower urinary tract symptoms who had urinary tract infection who a history of prostate biopsy and previous high level of PSA who history of prostatitis were excluded.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omer G Doluoglu, Associate Professor

Phone

+905332157809

drdoluoglu@yahoo.com.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omer G Doluoglu, Associate Professor

Organizational Affiliation

Ankara Training and Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Omer Gokhan Doluoglu

City

Ankara

State/Province

Altindag

ZIP/Postal Code

06100

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omer G Doluoglu

Phone

+905332157809

drdoluoglu@yahoo.com.tr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Changing of Prostate Specific Antigen Value in Patients With Covid-19

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