Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor

NCT04100733 | Active Not Recruiting

• 1 other identifier: SEALS Xpert
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 3

Brief Summary

The study aims to evaluate the potential clinical impact of a highly sensitive urinary marker, the Xpert Bladder Cancer Monitor, regarding possible reduction in number of flexible cystoscopies in an outpatient setting without decreasing recurrence-free survival or increasing risk of progression.

Conditions

Non-muscle Invasive Bladder Cancer; Urinary Biomarker

Keywords

Flexible cystoscopy; Xpert Bladder Cancer Monitor

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  Time from inclusion to detection of recurrence of bladder cancer.

  2 years follow-up per patient

Study Arms (2)

Control

ACTIVE COMPARATOR

Study subjects will cohere to current clinical guidelines for follow-up regimes of HG NMIBC with flexible cystoscopy and cytology every four months for a period of two years.

Diagnostic Test: Flexible cystoscopy (WL/NBI) and urinary cytology

Intervention

EXPERIMENTAL

Patients in the interventional arm will be followed at 4, 8, 16 and 20 months after inclusion with Xpert Bladder Cancer Monitor-test (and urinary cytology) instead of flexible cystoscopy.

Diagnostic Test: Xpert Bladder Cancer Monitor

Interventions

Xpert Bladder Cancer Monitor DIAGNOSTIC_TEST

Xpert Bladder Cancer Monitor detects mRNA fragments from 5 genes frequently overexpressed in non-muscle invasive bladder cancer.

Intervention

Flexible cystoscopy (WL/NBI) and urinary cytology DIAGNOSTIC_TEST

Adhering to current danish guidelines for follow-up of non-muscle invasive bladder cancer.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years of age at the time of signing the Informed Consent Form
• Ability to understand the Participant Information sheet orally and in writing
• Signed Informed Consent Form
• Is, according to the investigator's judgement, able to comply with the trial protocol

You may not qualify if:

• History of any upper urinary tract tumor regardless of grade and stage within the last 5 years prior to randomization
• T1 tumor where re-resection has not been performed
• CIS or invasive tumor within 3 months before randomization

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead
• Cepheid: collaborator

Study Sites (3)

Hospital of West Jutland

Holstebro, Danmark, 7500, Denmark

Location

Aarhus University Hospital

Århus N, 8200, Denmark

Location

Zealand University Hospital

Roskilde, Denmark

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, consultant

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

DK (3)