Investigation of the Diagnostic Role of miRNAs in PCa and BPH

December 5, 2024 updated by: Ali AKKOC, Alanya Alaaddin Keykubat University

Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia

Prostate cancer(PCa) is the second most common cause of cancer-related death in men after lung cancer. Diagnostic methods such as measurement of serum Prostate-specific antigen (PSA) levels used in the clinic still cannot distinguish between benign conditions and prostate cancer, and biopsy is essential for the diagnosis of prostate cancer. Due to the high false-positive rate of PSA, many patients are accidentally biopsied, which carries various risks for patients. Therefore, there is a need for new diagnostic methods to support PSA and the identification of reliable biomarkers for early diagnosis.

microRNAs (miRNAs) are short non-coding RNAs that can be detected in body fluids such as urine, blood and serum. In recent years, miRNAs have been nominated as reliable biomarkers that help us make an accurate diagnosis in many diseases, such as cancer. Although various miRNAs have been detected in the sera of prostate cancer patients, there is still little data on which miRNAs can be used as biomarkers.

In this study, investigators aimed to evaluate the expression levels of miR-107, miR-134-5p, miR-149-5p, miR-370-3p and miR-221 in blood as biomarkers capable of distinguishing PCa from benign prostatic hyperplasia (BPH) and will prevent unnecessary biopsies. In addition, they aimed to compare some clinical features such as serum PSA and Gleason Score with serum miRNA levels and determine the relationship between them.

Study Overview

Status

Completed

Conditions

Detailed Description

The present study is a prospective study and consists of three work packages. First, clinical evaluations were made and biopsy samples were taken from patients who applied to the urology clinic, had serum PSA levels higher than 4 ng/ML, and were suspected of prostate cancer. Then, a pathological examination of the biopsy samples was performed and the patients were grouped into PCA and BPH. Finally, molecular analyses were performed on blood samples obtained from patients and healthy controls and all obtained data were statistically evaluated.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07400
        • Alanya Alaaddin Keykubat University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.

Description

Inclusion Criteria:

  • For all groups, between 40-70 years of age.
  • Prostate cancer group: Patients with positive digital rectal examination (DRE) results, serum PSA level above 4 ng/mL and a confirmed pathological diagnosis of Prostate cancer.
  • BPH group: Patients with a PSA level over 4 ng/mL and a negative DRE result who were clinically and pathologically diagnosed with BPH.
  • Control: Healthy volunteers who applied to the urology outpatient clinic for routine check-ups and whose PSA value was below 4 ng/ml.

Exclusion Criteria:

  • To have undergone drug therapy or surgery for prostate cancer,
  • To have chronic inflammatory or infectious diseases,
  • Were hospitalized within the past year for a chronic illness,
  • To have another known malignancy,
  • Being outside the age limit of 40-70.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy control
Prostate Cancer
Prostate Cancer Patients
Benign Prostatic Hyperplasia
Benign prostatic hyperplasia(BPH) patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of miRNA expressions
Time Frame: March 2023
Five different miRNAs will be evaluated in the study: miR-107, miR-134-5p, miR-149-5p, miR-370-3p and miR-221
March 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Investigators

  • Study Chair: Ali AKKOÇ, Alanya Alaaddin Keykubat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

November 16, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10354421-2020/16-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study included 20 PCa and 17 BPH patients who were clinically and pathologically confirmed, aged between 40 and 70, and had serum PSA levels above 4 ng/mL. Additionally, 20 healthy volunteers were included in the study as the control group.

The clinical diagnosis of patients included in the study was conducted at the University Training and Research Hospital Urology Outpatient Clinic, with pathological assessments performed in the Pathology Laboratory. miRNA expression analyses were performed using quantitative real-time polymerase chain reaction (qRT- PCR) in peripheral blood samples.

All statistical analyses were performed using GraphPad Prism-5 (ver.9.0). Analyses were performed using the Kruskal-Wallis rank or Mann Whitney-U test and Spearman's test was used for correlation analysis. The role of miRNAs as biomarkers in PCa was investigated by drawing the receiver operating characteristic (ROC) curves. Statistical significance was taken as p <0.05.

IPD Sharing Time Frame

Ethical approval: 13.02.2020; Project start and completion: 01.06.2020-02.03.2023; Patient registration start and completion: 26.01.2021-05.12.2022; The project duration lasted 2 years and 9 months in total.

IPD Sharing Access Criteria

IPD and any additional supporting information can be shared with investigators who write about Prostate cancer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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