Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate CancerNCT04835454
Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer
An observational study of Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate Cancer, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate Cancer
- What is being tested?
- piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- • 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.
Who cannot join
- • Other coexisting cancers,
- Prostate cancer treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut, 71111
Heba Magdy, Assist lecturer, 01066005537, hebamagdy990@yahoo.com
Tahia Hashim, Professor, 01060560791, tahia.saleem@yahoo.com
About this study
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
Read the 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.
- Being tested
- piRNAs, miRNA-194, regucalcin and plasma aminoacids levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piRNAs, miRNA-194, regucalcin and plasma aminoacids levelsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels | |
| 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 Receives: Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels | |
| 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 Receives: Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 May 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Magdy Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835454
- Sponsor's protocol ID
- pmapc
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28267449
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04835454
- Acronym / sponsor ID
- pmapc
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levelsThe 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. |
| Prostate cancer group | – | Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levelsPatients 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 |
| benign prostatic hyperplasia group | – | Diagnostic Test: piRNAs, miRNA-194, regucalcin and plasma aminoacids levelsPatients who are confirmed to have benign prostatic hyperplasia based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- • 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
Key exclusion criteria (2 listed)
- • Other coexisting cancers,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piRNAs, miRNA-194, regucalcin and plasma aminoacids levelsPIWI-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. | Diagnostic test | Prostate cancer group, benign prostatic hyperplasia group, control group |
Primary outcome
• 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
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 28267449Savir-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Finding New Biomarkers That Could be Evaluated in Patients With Prostate Cancer and Clarify Their Role in Early Detection of Prostate Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.