NCT04317261

Brief Summary

Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

Study Start

First participant enrolled

March 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 4, 2020

Last Update Submit

March 19, 2020

Conditions

HematuriaBladder Cancer

Keywords

HematuriaBladder cancerBiomarkersmRNACytologymetabolomics

Outcome Measures

Primary Outcomes (2)

  • Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test

    Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test for bladder cancer detection in patients with hematuria

    1 year

  • Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC)

    Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC) for bladder cancer detection in patients with hematuria

    1 year

Study Arms (1)

Hematuria patients

EXPERIMENTAL
Diagnostic Test: Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)

Interventions

Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)DIAGNOSTIC_TEST

Urine sample is evaluated for RNA and urinary metabolites

Hematuria patients

Eligibility Criteria

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

You may qualify if:

  • Patients with gross or persistent microscopic hematuria with irritative bladder symptoms

You may not qualify if:

  • patients on anticoagulants
  • patients with history of radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

HematuriaUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUrinary Bladder Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 23, 2020

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations

EG(1)