NCT03591367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 4, 2019

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

July 8, 2018

Last Update Submit

November 1, 2019

Conditions

Bladder CancerBladder DiseaseBladder NeoplasmMicro-RNA

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (1)

  • correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer

    1 year

Study Arms (1)

Hematuria due to suspicious superficial bladder tumor

OTHER

MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT)

Diagnostic Test: MicroRNAs-155Diagnostic Test: Human telomerase reverse transcriptase

Interventions

MicroRNAs-155DIAGNOSTIC_TEST

Quantitative analysis of cell-free miR-155 using RT-qPCR.

Also known as: (miRNAs-155)
Hematuria due to suspicious superficial bladder tumor
Human telomerase reverse transcriptaseDIAGNOSTIC_TEST

Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.

Also known as: (hTERT)
Hematuria due to suspicious superficial bladder tumor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 years or older.
  • Patient with hematuria suspected to be of bladder origin clinically.
  • Willing to be participate in the study.

You may not qualify if:

  • Patient having another malignancy.
  • Hematuria of other causes as trauma and stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed Mosbah, MD

    Urology and nephrology center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 19, 2018

Study Start

August 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 4, 2019

Record last verified: 2018-07

Locations

EG(1)