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Investigation of the Diagnostic Role of miRNAs in PCa and BPH

NCT ID: NCT06726070

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-03-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Benign Prostate Hypertrophy(BPH) Prostate Cancer (Adenocarcinoma)

Keywords

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prostate cancer Benign Prostate Hypertrophy(BPH) miRNA biomarker PSA

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Prostate Cancer

Prostate Cancer Patients

No interventions assigned to this group

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia(BPH) patients

No interventions assigned to this group

Control

Healthy control

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alanya Alaaddin Keykubat University

OTHER

Sponsor Role lead

Responsible Party

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Ali AKKOC

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali AKKOÇ

Role: STUDY_CHAIR

Alanya Alaaddin Keykubat University

Locations

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Alanya Alaaddin Keykubat University Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 39311384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29506516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28454346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33331954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27573045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32213205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27990656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28445135 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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10354421-2020/16-24

Identifier Type: -

Identifier Source: org_study_id