NCT05362539

Brief Summary

The current study aimed to assess the diagnostic performance of novel urine-based DNA hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) for UBC detection in patients with hematuria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

April 27, 2022

Last Update Submit

April 30, 2022

Conditions

Bladder Cancer

Keywords

Urothelial bladder carcinomaBladder cancerHematuriaBiomarkersDNA methylation

Outcome Measures

Primary Outcomes (1)

  • Rate of hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) in patients with urothelial bladder carcinoma

    Rate of hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) in patients with urothelial bladder carcinoma

    4 weeks

Study Arms (1)

Hematuria patients

EXPERIMENTAL

Voided urine was collected from consecutive patients presented with hematuria at our institute for urine cytology and DNA hypermethylation assay of the assigned genes using methylation-specific Polymerase Chain Reaction (PCR). Further assessment by office cystoscopy and imaging with subsequent inpatient cystoscopic biopsy for positive findings, was done. The diagnostic characteristics of DNA hypermethylation and urine cytology were assessed based on its capability to predict UBC noninvasively

Procedure: CystoscopyDiagnostic Test: Computed tomographyGenetic: DNA hypermethylation assayDiagnostic Test: Urine cytology

Interventions

CystoscopyPROCEDURE

diagnostic cystoscopy for detection of any bladder lesions

Hematuria patients
Computed tomographyDIAGNOSTIC_TEST

Computed tomography for patients to exclude bladder lesions

Hematuria patients
DNA hypermethylation assayGENETIC

DNA hypermethylation assay of six genes (GATA4, P16, P14, APC, CDH1 and CD99)

Hematuria patients
Urine cytologyDIAGNOSTIC_TEST

voided urine cytology for all patients

Hematuria patients

Eligibility Criteria

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

You may qualify if:

  • patients with hematuria (macroscopic or microscopic)

You may not qualify if:

  • history of Bladder Cancer
  • history of pelvic irradiation,
  • bleeding diathesis or receiving anticoagulants
  • patients with upper urinary tract neoplasm or urolithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHematuria

Interventions

CystoscopyTomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUrination DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical ProceduresImage Interpretation, Computer-AssistedDiagnostic ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Amr A Elsawy

    Mansoura University

    PRINCIPAL INVESTIGATOR

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
Lecturer of Urology

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 5, 2022

Study Start

February 1, 2019

Primary Completion

June 1, 2021

Study Completion

April 1, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)