NCT06726070|Completed
Investigation of the Diagnostic Role of miRNAs in PCa and BPH
Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia
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Investigation of Candidate miRNAs as Potential Biomarkers in the Early Diagnosis of Prostate Cancer and Benign Prostate Hyperplasia
Sponsor study identifier
observational
57
1 country
1
Study Start
June 1, 2020
Actual (reported)Primary Completion
December 5, 2022
Actual (reported)Study Completion
March 2, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2020
Actual (reported)December 5, 2022
Actual (reported)March 2, 2023
Actual (reported)November 16, 2024
Actual (reported)December 10, 2024
Actual (reported)Evaluation of miRNA expressions
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
Prostate Cancer Patients
Benign prostatic hyperplasia(BPH) patients
Healthy control
Patients applying to the Urology Clinic of Alanya Alaaddin Keykubat University Training and Research Hospital.
Alanya Alaaddin Keykubat University Training and Research Hospital
Antalya, 07400, Turkey (Türkiye)
Puente-Rivera J, De la Rosa Perez DA, Olvera SIN, Figueroa-Angulo EE, Saucedo JGC, Hernandez-Leon O, Alvarez-Sanchez ME. The Circulating miR-107 as a Potential Biomarker Up-Regulated in Castration-Resistant Prostate Cancer. Noncoding RNA. 2024 Aug 24;10(5):47. doi: 10.3390/ncrna10050047.
Shao N, Ma G, Zhang J, Zhu W. miR-221-5p enhances cell proliferation and metastasis through post-transcriptional regulation of SOCS1 in human prostate cancer. BMC Urol. 2018 Mar 5;18(1):14. doi: 10.1186/s12894-018-0325-8.
Ali AKKOÇ
Alanya Alaaddin Keykubat University
57 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2024
First Posted
December 10, 2024
Study Start
June 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Su X, Zhang L, Li H, Cheng P, Zhu Y, Liu Z, Zhao Y, Xu H, Li D, Gao H, Zhang T. MicroRNA-134 targets KRAS to suppress breast cancer cell proliferation, migration and invasion. Oncol Lett. 2017 Mar;13(3):1932-1938. doi: 10.3892/ol.2017.5644. Epub 2017 Jan 25.
Pelka K, Klicka K, Grzywa TM, Gondek A, Marczewska JM, Garbicz F, Szczepaniak K, Paskal W, Wlodarski PK. miR-96-5p, miR-134-5p, miR-181b-5p and miR-200b-3p heterogenous expression in sites of prostate cancer versus benign prostate hyperplasia-archival samples study. Histochem Cell Biol. 2021 Mar;155(3):423-433. doi: 10.1007/s00418-020-01941-2. Epub 2020 Dec 17.
Chen Y, Zhao J, Luo Y, Wang Y, Jiang Y. Downregulated expression of miRNA-149 promotes apoptosis in side population cells sorted from the TSU prostate cancer cell line. Oncol Rep. 2016 Nov;36(5):2587-2600. doi: 10.3892/or.2016.5047. Epub 2016 Aug 25.
Nayak B, Khan N, Garg H, Rustagi Y, Singh P, Seth A, Dinda AK, Kaushal S. Role of miRNA-182 and miRNA-187 as potential biomarkers in prostate cancer and its correlation with the staging of prostate cancer. Int Braz J Urol. 2020 Jul-Aug;46(4):614-623. doi: 10.1590/S1677-5538.IBJU.2019.0409.
Foj L, Ferrer F, Serra M, Arevalo A, Gavagnach M, Gimenez N, Filella X. Exosomal and Non-Exosomal Urinary miRNAs in Prostate Cancer Detection and Prognosis. Prostate. 2017 May;77(6):573-583. doi: 10.1002/pros.23295. Epub 2016 Dec 19.
Vanacore D, Boccellino M, Rossetti S, Cavaliere C, D'Aniello C, Di Franco R, Romano FJ, Montanari M, La Mantia E, Piscitelli R, Nocerino F, Cappuccio F, Grimaldi G, Izzo A, Castaldo L, Pepe MF, Malzone MG, Iovane G, Ametrano G, Stiuso P, Quagliuolo L, Barberio D, Perdona S, Muto P, Montella M, Maiolino P, Veneziani BM, Botti G, Caraglia M, Facchini G. Micrornas in prostate cancer: an overview. Oncotarget. 2017 Jul 25;8(30):50240-50251. doi: 10.18632/oncotarget.16933.
Primary Completion
December 5, 2022
Actual (reported)Study Completion
March 2, 2023
Actual (reported)Last Updated
December 10, 2024
Record last verified: 2024-12
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.
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