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NCT05080998 · ClinicalTrials.gov registry record

Longitudinal Bladder Cancer Study for Tumour Recurrence

A clinical trial of Urothelial Bladder Cancer, sponsored by Pacific Edge Limited.

Recruiting
Registry status
450
Enrollment target
7
Study locations

NCT05080998 is a study of Urothelial Bladder Cancer that is actively recruiting participants, run by Pacific Edge Limited. The registered enrollment target is 450 participants. The trial reports 7 study locations across 6 states.

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The verdict

NCT05080998, a study of Urothelial Bladder Cancer, is actively recruiting participants, sponsored by Pacific Edge Limited.

RECRUITING
Registry status
450 participants
Enrollment target
7
Study locations

Study Summary

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST CxBladder Monitor/Monitor+

Study Locations (7)

Florida

  • Miami VA Healthcare System - Miami
  • James A. Haley Veteran's Hospital - Tampa

South Carolina

  • Ralph H. Johnson VA Health Care System - Charleston

Texas

  • UT Southwestern Medical Center - Dallas

Vermont

  • White River Junction Veterans Affair Medical Center - White River Junction

Washington

  • University of Washington School of Medicine - Seattle

Victoria

  • Monash Health - Moorabbin Hospital - Clayton

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2022-06-08
Est. Completion 2026-08-31

Sponsor

Pacific Edge Limited

6 total trials

What the Registry Record Tells You About NCT05080998

The ClinicalTrials.gov registry entry for NCT05080998 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacific Edge Limited, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urothelial Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which CxBladder Monitor/Monitor+ is the first listed.

NCT05080998 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Florida, South Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT05080998 about?

NCT05080998 is a clinical study titled "Longitudinal Bladder Cancer Study for Tumour Recurrence". Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm,...

What is the current status of trial NCT05080998?

This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2022-06-08. Estimated completion is 2026-08-31.

What conditions does trial NCT05080998 study?

This clinical trial studies the following conditions: Urothelial Bladder Cancer.

What interventions are being tested in trial NCT05080998?

The interventions under investigation include: CxBladder Monitor/Monitor+ (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05080998?

This trial is sponsored by Pacific Edge Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05080998 being conducted?

This trial has 7 study locations across Florida, South Carolina, Texas, Vermont, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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