Prostate InfectionNCT05399940
The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters
An observational study of Prostate Infection and Prostate Disease, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis. Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Infection, Prostate Disease, Prostate Cancer
- What is being tested?
- Serum PSA,Delta Neutrophil Index(DNI),WBC
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 20 May 2022
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult male patients with acute prostatitis were included in the study.
Who may be able to join
- Acute prostatitis Male
- -
Who cannot join
- Prostate cancer Chronic prostatitis Other Urinary infections,
- -
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:
To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis.
Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.
Read the detailed description
Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.
WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT, RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic therapy
- Conditions
- Prostate Infection, Prostate Disease, Prostate Cancer
- Being tested
- Serum PSA,Delta Neutrophil Index(DNI),WBC
- Keywords
- prostatit
- Medical subject headings
- Prostatic Diseases, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum PSA,Delta Neutrophil Index(DNI),WBCDiagnostic test
Also called MPV,NLR,RDW
Urine culture, prostate volume
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | :PSA<4 ng/mL Receives: Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC | |
| Group 2 | PSA>4 ng/mL Receives: Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jan 2018
- Primary completion1 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399940
- Sponsor's protocol ID
- 22/5-27
- Status last verified
- May 2022
- First submitted
- 27 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: re
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters
- ClinicalTrials.gov ID
- NCT05399940
- Acronym / sponsor ID
- 22/5-27
- Conditions
- Prostate Infection, Prostate Disease, Prostate Cancer
- Keywords
- prostatit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis.
Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.
Detailed description
Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.
WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT, RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic therapy
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC:PSA<4 ng/mL |
| Group 2 | – | Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBCPSA>4 ng/mL |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients with acute prostatitis were included in the study.
Key inclusion criteria (2 listed)
- Acute prostatitis Male
- -
Key exclusion criteria (2 listed)
- Prostate cancer Chronic prostatitis Other Urinary infections,
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum PSA,Delta Neutrophil Index(DNI),WBCAlso: MPV,NLR,RDWUrine culture, prostate volume | Diagnostic test | Group 1, Group 2 |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Yes. re
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Infection and Prostate Disease, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration Versus Time Curve (AUC) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.