Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04835454
Collaborator
(none)
120
1
7
17.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer
Anticipated Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
Sep 15, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
control group

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.

Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. 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. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.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.

Prostate cancer group

Patients who are confirmed to have prostate cancer based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue with no other coexisting cancers or prostate cancer treatment

Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. 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. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.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.

benign prostatic hyperplasia group

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

Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. 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. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.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.

Outcome Measures

Primary Outcome Measures

  1. • 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 [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Heba Magdy Mohammed, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04835454
Other Study ID Numbers:
  • pmapc
First Posted:
Apr 8, 2021
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021