The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation

November 1, 2019 updated by: Mansoura University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Aldakahlia
      • Mansourah, Aldakahlia, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hematuria due to suspicious superficial bladder tumor
MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT)
Diagnostic test: MicroRNAs-155
Quantitative analysis of cell-free miR-155 using RT-qPCR.
Other Names:
  • (miRNAs-155)
Diagnostic test: Human telomerase reverse transcriptase
Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.
Other Names:
  • (hTERT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
Time Frame: 1 year
measured serum Vit D in ng/mL.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

July 8, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MicroRNA-155 Bladder Cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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