Bladder CancerNCT01166230
Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
An observational study of Bladder Cancer, run by Photocure at 24 sites in 5 countries.
Trial summary
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 551 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Jun 2010to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients with non-invasive papillary bladder cancer, enrolled in the previously completed pivotal phase III study PC B305/04, who were followed for recurrence will be included in this study.
Who may be able to join
- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.
Who cannot join
- Patient died during clinical study PC B305/04
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States14 sites
The Emory Clinic, Dept of Urology
Atlanta, Georgia, 30322
Boston University School of Medicine
Boston, Massachusetts, 02118
V.A. Medical Center
Gainesville, Florida, 32608
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030-2726
The University of Texas MD Anderson cancer center
Houston, Texas, 77030-4009
University of Miami School of Medicine
Miami, Florida, 33136
Vanderbilt University Medical Center, Department of Urologic Surgery
Nashville, Tennessee, 37232-2765
Mount Sinai Medical Center, Department of Urology
New York, New York, 10029-6574
South Florida Clinical Research Center, Inc.
Pembroke Pines, Florida, 33028
Thomas Jefferson Medical College, Department of Neurology
Philadelphia, Pennsylvania, 19107
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
Rochester, Minnesota, 55905
URMC
Rochester, New York, 14642
Stanford Cancer Center, Department of Urology
Stanford, California, 94305-5820
Germany5 sites
University Clinic of Giessen, Department of Urology
Giessen, 35392
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
München, 81377
Urologische Klinik München-Planegg
Planegg, 82152
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
Regensburg, 93053
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
Tübingen, 72076
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
CHUQ Hotel-Dieu de Quebec
Québec, G1R 2J6
Netherlands2 sites
Department of Urology, Academic Medical Center, University of Amsterdam
Amsterdam, 1105 AZ
Department of Urology, UMC St. Radboud
Nijmegen, 6500 HB
About this study
Official title: An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Read the detailed description
A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.
The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
No safety data was collected.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ta/T1, randomized to white light cystoscopy | Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence. | |
| Patients with Ta/T1 randomized to Hexvix cystoscopy | Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
Measured: up to 4.5 years
Secondary outcomes (1)
Rate of Progression
Only patients with Ta/T1 were included in the follow-up study. "Progression" is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Barton Grossman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166230
- Sponsor's protocol ID
- PC B305/E10
- Status last verified
- Mar 2019
- First submitted
- 19 Jul 2010
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB
- ClinicalTrials.gov ID
- NCT01166230
- Acronym / sponsor ID
- PC B305/E10
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Posted 14 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
Detailed description
A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.
The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.
No safety data was collected.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Ta/T1, randomized to white light cystoscopy | – | –Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence. |
| Patients with Ta/T1 randomized to Hexvix cystoscopy | – | –Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-invasive papillary bladder cancer, enrolled in the previously completed pivotal phase III study PC B305/04, who were followed for recurrence will be included in this study.
Key inclusion criteria (1 listed)
- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.
Key exclusion criteria (1 listed)
- Patient died during clinical study PC B305/04
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence Free Survival
Time frame: up to 4.5 years
1 secondary outcome
Rate of Progression
Time frame: 4.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Bladder Cancer Advocacy Network (BCAN)Link provided by the sponsor.
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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.
Herbert Barton Grossman, MD principal investigator
M.D. Anderson Cancer Center
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Photocure at 24 sites in 5 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, Canada, Netherlands, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: up to 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019.