NCT03427034

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,100

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2018

Status
unknown

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

First Submitted

Initial submission to the registry

January 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2.1 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
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

January 30, 2018

Last Update Submit

February 2, 2018

Conditions

Bladder Cancer

Keywords

UrineHaematuriaFlexible cystoscopyRecurrenceCytology

Outcome Measures

Primary Outcomes (1)

  • To exclude presence of bladder cancer with sensitivity of 85%

    In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.

    12 month

Study Arms (3)

Cystoscopic surveillance

EXPERIMENTAL

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

Device: BladderLight®

Haematuria group

EXPERIMENTAL

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

Device: BladderLight®

Longitudinal group

NO INTERVENTION

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

Interventions

BladderLight®DEVICE

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

Cystoscopic surveillanceHaematuria group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years of age or above.
  • 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.
  • Able to understand and sign the written Informed Consent Form.
  • Able and willing to follow the Protocol requirements

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saeb-Parsy K, Wilson A, Scarpini C, Corcoran M, Chilcott S, McKean M, Thottakam B, Rai B, Nabi G, Rana D, Perera M, Stewart K, Laskey RA, Neal DE, Coleman N. Diagnosis of bladder cancer by immunocytochemical detection of minichromosome maintenance protein-2 in cells retrieved from urine. Br J Cancer. 2012 Oct 9;107(8):1384-91. doi: 10.1038/bjc.2012.381. Epub 2012 Sep 11.

    PMID: 22968648BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHematuriaRecurrence

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 SymptomsDisease Attributes

Study Officials

  • kasra Saeb-Parsy, MBBS, FRCSEd

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kasra Paeb-Parsy, MBBS, FRCSEd

CONTACT

+44(0)7769714323kasra.saeb-parsy@nhs.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: all eligible patients will be recruited
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Urologist, Chief Investigator

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 9, 2018

Study Start

February 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 9, 2018

Record last verified: 2018-02