Bladder CancerPhase 2/3ABSEILNCT03427034
Assessment of BladderLight SurvEILlance
A Phase 2/3 study testing BladderLight® in people with Bladder Cancer, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- BladderLight®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Mar 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.
Read the detailed description
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
- Bladder Cancer
- Being tested
- BladderLight®
- Keywords
- Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology
- Medical subject headings
- Urinary Bladder Neoplasms, Hematuria, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BladderLight®Device
Using a cell collection device to look for the presence of bladder cancer cells
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- all eligible patients will be recruited
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cytosystems Ltd
- Responsible party
- Principal investigator, Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Cambridge University Hospitals NHS Foundation Trust
- Investigators
- kasra Saeb-Parsy, MBBS, FRCSEd, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427034
- Sponsor's protocol ID
- A094687
- Acronym
- ABSEIL
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be published in peer reviewed journals and presented at scientific meetings
Publications
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.
PubMed 22968648
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Specificity and Sensitivity of the BladderLight™ Assay as a Diagnostic and Risk Stratification Tool for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03427034
- Acronym / sponsor ID
- ABSEIL / A094687
- Conditions
- Bladder Cancer
- Keywords
- Urine, Haematuria, Flexible cystoscopy, Recurrence, Cytology
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cytosystems Ltd
- Study start
- Feb 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is BladderLight® (BL) urine testing accurate, as a non-invasive method, to exclude presence of bladder cancer in patients.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- all eligible patients will be recruited
| Arm | Type | Receives |
|---|---|---|
| Cystoscopic surveillance | Experimental | Device: BladderLight®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 |
| Haematuria group | Experimental | Device: BladderLight®Patients referred with haematuria to exclude bladder cancer will privide a urine sample to see if BladderLight system can exclude presence of bladder cancer |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BladderLight®Using a cell collection device to look for the presence of bladder cancer cells | Device | Cystoscopic surveillance, Haematuria group |
Primary outcome
To exclude presence of bladder cancer with sensitivity of 85%
Time frame: 12 month
In each cohort of the study sensitivity, specificity, negative and positive predictive value for detection of cancer will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 22968648Saeb-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.
- Individual participant dataSharing planned: Undecided. Data will be published in peer reviewed journals and presented at scientific meetings
Related trials for Bladder Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
Bladder Cancer
RecruitingPhase 3
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intermediate Risk Non-Muscle Invasive Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kasra Saeb-Parsy, MBBS, FRCSEd principal investigator
Cambridge University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BladderLight® in people with Bladder Cancer, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kasra Paeb-Parsy, MBBS, FRCSEd (+44(0)7769714323, kasra.saeb-parsy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To exclude presence of bladder cancer with sensitivity of 85% (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.