Back to resultsThe Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Primary Purpose
Bladder Cancer, Bladder Disease, Bladder Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MicroRNAs-155
Human telomerase reverse transcriptase
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
- Men and women 18 years or older.
- Patient with hematuria suspected to be of bladder origin clinically.
- Willing to be participate in the study.
Exclusion Criteria:
- Patient having another malignancy.
- Hematuria of other causes as trauma and stones
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hematuria due to suspicious superficial bladder tumor
Arm Description
MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
measured serum Vit D in ng/mL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03591367
Brief Title
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Official Title
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Bladder Disease, Bladder Neoplasm, Micro-RNA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hematuria due to suspicious superficial bladder tumor
Arm Type
Other
Arm Description
MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT)
Intervention Type
Diagnostic Test
Intervention Name(s)
MicroRNAs-155
Other Intervention Name(s)
(miRNAs-155)
Intervention Description
Quantitative analysis of cell-free miR-155 using RT-qPCR.
Intervention Type
Diagnostic Test
Intervention Name(s)
Human telomerase reverse transcriptase
Other Intervention Name(s)
(hTERT)
Intervention Description
Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.
Primary Outcome Measure Information:
Title
sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer
Description
compared by standard final pathological specimen
Time Frame
1 year
Secondary Outcome Measure Information:
Title
correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
Description
measured serum Vit D in ng/mL.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 18 years or older.
Patient with hematuria suspected to be of bladder origin clinically.
Willing to be participate in the study.
Exclusion Criteria:
Patient having another malignancy.
Hematuria of other causes as trauma and stones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mosbah, MD
Organizational Affiliation
Urology and nephrology center
Official's Role
Study Chair
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansourah
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
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