Assessment of BladderLight SurvEILlance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Diagnostic for the Early Detection of Bladder Cancer

NCT05347342

Bladder Cancer

ACTIVE_NOT_RECRUITING

The Cxbladder Rule-out of Recurrent Urothelial Carcinoma

NCT03673202

Bladder Cancer

UNKNOWN

Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

NCT02169284

Bladder Carcinoma Recurrent Bladder Carcinoma

TERMINATED PHASE2

Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder

NCT02745301

Bladder Cancer, Biomarkers

COMPLETED

Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02

NCT06780358

Bladder Cancer

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There are three arms to the proposed performance evaluation of the integrated test - arms 1 and 2 are cross-sectional studies examining the accuracy of the BladderLight® test in the detection of cancer of the urinary bladder in patients attending either Gross Haematuria clinic for a potential primary (first time) diagnosis (arm 1) or patients attending Cystsoscopic Surveillance clinic as follow up to a previous, treated case of bladder cancer (arm 2). Arm 3 is a longitudinal examination of disease state following a negative cystoscopy with a positive BladderLight® test - this will examine whether BladderLight® can predict progression to overt disease. Arm three will not involve any further requirement for physical sampling, but will involve result checking on subsequent cystoscopies

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

all eligible patients will be recruited

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cystoscopic surveillance

Patients with previous history of bladder cancer undergoing flexible cystoscopy will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer

Group Type EXPERIMENTAL

BladderLight®

Intervention Type DEVICE

Using a cell collection device to look for the presence of bladder cancer cells

Haematuria group

Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer

Group Type EXPERIMENTAL

BladderLight®

Intervention Type DEVICE

Using a cell collection device to look for the presence of bladder cancer cells

Longitudinal group

Patient with Negative cystoscopy with a positive BladderLight® test will be followed for 12 months to see if they subsequently develop bladder cancer.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BladderLight®

Using a cell collection device to look for the presence of bladder cancer cells

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18 years of age or above.
2. Patients attending Cystoscopic Surveillance clinic for monitoring of recurrence of urothelial carcinoma after having been treated for urothelial carcinoma / bladder cancer (Arm 1) OR Patients attending Gross Haematuria clinic (or equivalent) for cystoscopy/biopsy (if appropriate) relating to symptoms suggestive of possible urothelial cancer (Arm 2). Patients that will receive a cystoscopy as per standard practice.
3. Able to understand and sign the written Informed Consent Form.
4. Able and willing to follow the Protocol requirements

Exclusion Criteria

1. Participation in any clinical study of an Investigational Medicinal Product during the 8 weeks preceding the sampling period of the study.
2. Patients that have a urinary tract stent, kidney stones or catheter

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No