Clinical trial NCT04835454: Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer
Official title: Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are from Urology Department, Assiut university. Patient medical history will be obtained in details. Clinical data will include age , history of previous diseases and any investigations were done. Data registered for every patient using constructed patient sheets

Brief summary: Prostate cancer is one of the most frequently diagnosed cancers and one of the main causes of death due to tumors in men . The mechanisms of its carcinogenesis have not been fully elucidated yet . Prostate tumours remain undetected or dormant for a long period of time before they progress loco-regionally or at distant sites as overt tumours. The molecular mechanism of dormancy is yet poorly understood

Detailed description: Currently, early detection of prostate cancer involves mainly digital rectal examination (DRE) and testing of prostate-specific antigen (PSA) level in blood . However, over the years it became clear that PSA is not a specific biomarker of prostate cancer . Finding out new biomarkers is pivotal for early detection of prostate cancer, increasing the accuracy of diagnosis, and reducing the false positives in PSA testing These biomarkers include many biological compounds such as, microRNAs, small nuclear RNAs (sncRNA), proteins and metabolites .

PIWI-interacting RNAs (piRNAs), a class of sncRNA molecules, are associated with the PIWI proteins. Moreover, MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs\[15\]. Studies have shown that the miRNAs have critical roles in a variety of biological processes such as: cell proliferation, differentiation, apoptosis and carcinogenesis. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions. Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.

Eligibility criteria: Inclusion Criteria:

* • Patients who are confirmed to have prostate cancer or benign prostatic hyperplasia based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue

  * The control group consisted of healthy men with no cancer and no chronic diseases. They will be age-matched with patient group and recruited among men subjected to the routine periodic medical examination.

Exclusion Criteria:

* • Other coexisting cancers,

  * Prostate cancer treatment

Primary outcomes:
measure: • To investigate the role of piRNAs, miRNA-194, regucalcin and aminoacids in prostate cancer development. and highlight their potential clinical utilities as biomarkers as well as potential targets for cancer treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Savir-Baruch B, Zanoni L, Schuster DM. Imaging of Prostate Cancer Using Fluciclovine. PET Clin. 2017 Apr;12(2):145-157. doi: 10.1016/j.cpet.2016.11.005. Epub 2017 Jan 23.