Bladder CancerNCT03591367
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
A study testing MicroRNAs-155 and Human telomerase reverse transcriptase in people with Bladder Cancer and Bladder Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Disease, Bladder Neoplasm
- What is being tested?
- MicroRNAs-155 and Human telomerase reverse transcriptase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 May 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years or older.
- Patient with hematuria suspected to be of bladder origin clinically.
- Willing to be participate in the study.
Who cannot join
- Patient having another malignancy.
- Hematuria of other causes as trauma and stones
Trial locations and contacts
1 site in 1 country.
About this study
We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.
- Conditions
- Bladder Cancer, Bladder Disease, Bladder Neoplasm, Micro-RNA
- Being tested
- MicroRNAs-155, Human telomerase reverse transcriptase
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroRNAs-155Diagnostic test
Also called (miRNAs-155)
Quantitative analysis of cell-free miR-155 using RT-qPCR.
Human telomerase reverse transcriptaseDiagnostic test
Also called (hTERT)
Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.
| Study group | Role | What they receive |
|---|---|---|
| Hematuria due to suspicious superficial bladder tumor | Other | MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT) Receives: Diagnostic Test: MicroRNAs-155; Diagnostic Test: Human telomerase reverse transcriptase |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer
compared by standard final pathological specimen
Measured: 1 year
Secondary outcomes (1)
correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
measured serum Vit D in ng/mL.
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 posted19 Jul 2018
- Study start1 Aug 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Mosbah, MD, Study chair, Urology and nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591367
- Sponsor's protocol ID
- MicroRNA-155 Bladder Cancer
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
- ClinicalTrials.gov ID
- NCT03591367
- Acronym / sponsor ID
- MicroRNA-155 Bladder Cancer
- Conditions
- Bladder Cancer, Bladder Disease, Bladder Neoplasm, Micro-RNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 19 Jul 2018 (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.
We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematuria due to suspicious superficial bladder tumor | Other | Diagnostic Test: MicroRNAs-155, Diagnostic Test: Human telomerase reverse transcriptaseMicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18 years or older.
- Patient with hematuria suspected to be of bladder origin clinically.
- Willing to be participate in the study.
Key exclusion criteria (2 listed)
- Patient having another malignancy.
- Hematuria of other causes as trauma and stones
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 |
|---|---|---|
| MicroRNAs-155Also: (miRNAs-155)Quantitative analysis of cell-free miR-155 using RT-qPCR. | Diagnostic test | Hematuria due to suspicious superficial bladder tumor |
| Human telomerase reverse transcriptaseAlso: (hTERT)Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction. | Diagnostic test | Hematuria due to suspicious superficial bladder tumor |
Primary outcome
sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer
Time frame: 1 year
compared by standard final pathological specimen
1 secondary outcome
correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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.
Ahmed Mosbah, MD study chair
Urology and nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicroRNAs-155 and Human telomerase reverse transcriptase in people with Bladder Cancer and Bladder Disease, run by Mansoura 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 3 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: finished, as of the sponsor's last update on 4 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2019.