Non Muscle Invasive Bladder CancerNCT01004211
Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging
A study testing Narrow band imaging transurethral resection and Standard transurethral resection in people with Non Muscle Invasive Bladder Cancer, run by Paolo Puppo at 2 sites in Italy.
Trial summary
To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Narrow band imaging transurethral resection and Standard transurethral resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2009to Oct 2011
- Phase
- Interventional
- 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
- All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded.
- All patients will provide a written informed consent prior to the study.
- Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms.
Who cannot join
- Patients with muscle invasive bladder cancer will be excluded.
- Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
National Institute for Cancer Research (IST)
Genoa, 16132
Centro Urologico di Eccellenza ASL 1
Imperia
About this study
Official title: A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Narrow band imaging transurethral resection, Standard transurethral resection
- Keywords
- bladder cancer, recurrence
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band imaging transurethral resectionProcedure or surgery
Transurethral resection of bladder lesion by mean of narrow band imaging
Standard transurethral resectionProcedure or surgery
Transurethral resection of bladder lesion by mean of standard white light
| Study group | Role | What they receive |
|---|---|---|
| Standard transurethral resection | Active comparator | Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer Receives: Procedure: Standard transurethral resection |
| Narrow band imaging transurethral resection | Experimental | The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer. Receives: Procedure: Narrow band imaging transurethral resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival rate
Measured: One year
Secondary outcomes (1)
Detection rate
Measured: At the end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non Muscle Invasive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Puppo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Puppo, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Paolo Puppo, MD, Principal investigator, National Institute for Cancer Research, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004211
- Sponsor's protocol ID
- IST-NBI-2009
- Status last verified
- Jan 2018
- First submitted
- 28 Oct 2009
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Narrow band imaging for detecting residual/recurrent cancerous tissue during second transurethral resection of newly diagnosed non-muscle-invasive high-grade bladder cancer. BJU Int. 2010 Jan;105(2):208-11. doi: 10.1111/j.1464-410X.2009.08701.x. Epub 2009 Jun 22.
PubMed 19549255Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Feasibility of transurethral resection of bladder lesion performed entirely by means of narrow-band imaging. J Endourol. 2010 Jul;24(7):1131-4. doi: 10.1089/end.2010.0042.
PubMed 20509796Naselli A, Introini C, Timossi L, Spina B, Fontana V, Pezzi R, Germinale F, Bertolotto F, Puppo P. A randomized prospective trial to assess the impact of transurethral resection in narrow band imaging modality on non-muscle-invasive bladder cancer recurrence. Eur Urol. 2012 May;61(5):908-13. doi: 10.1016/j.eururo.2012.01.018. Epub 2012 Jan 20.
PubMed 22280855
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
- ClinicalTrials.gov ID
- NCT01004211
- Acronym / sponsor ID
- IST-NBI-2009
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- bladder cancer, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Paolo PuppoUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- 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.
To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard transurethral resection | Active comparator | Procedure: Standard transurethral resectionPatients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer |
| Narrow band imaging transurethral resection | Experimental | Procedure: Narrow band imaging transurethral resectionThe system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded.
- All patients will provide a written informed consent prior to the study.
- Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms.
Key exclusion criteria (2 listed)
- Patients with muscle invasive bladder cancer will be excluded.
- Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.
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 |
|---|---|---|
| Narrow band imaging transurethral resectionTransurethral resection of bladder lesion by mean of narrow band imaging | Procedure or surgery | Narrow band imaging transurethral resection |
| Standard transurethral resectionTransurethral resection of bladder lesion by mean of standard white light | Procedure or surgery | Standard transurethral resection |
Primary outcome
Recurrence free survival rate
Time frame: One year
1 secondary outcome
Detection rate
Time frame: At the end of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 19549255Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Narrow band imaging for detecting residual/recurrent cancerous tissue during second transurethral resection of newly diagnosed non-muscle-invasive high-grade bladder cancer. BJU Int. 2010 Jan;105(2):208-11. doi: 10.1111/j.1464-410X.2009.08701.x. Epub 2009 Jun 22.
- Results publication: PubMed 20509796Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Feasibility of transurethral resection of bladder lesion performed entirely by means of narrow-band imaging. J Endourol. 2010 Jul;24(7):1131-4. doi: 10.1089/end.2010.0042.
- Results publication: PubMed 22280855Naselli A, Introini C, Timossi L, Spina B, Fontana V, Pezzi R, Germinale F, Bertolotto F, Puppo P. A randomized prospective trial to assess the impact of transurethral resection in narrow band imaging modality on non-muscle-invasive bladder cancer recurrence. Eur Urol. 2012 May;61(5):908-13. doi: 10.1016/j.eururo.2012.01.018. Epub 2012 Jan 20.
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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.
Paolo Puppo, MD principal investigator
National Institute for Cancer Research, Genoa, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band imaging transurethral resection and Standard transurethral resection in people with Non Muscle Invasive Bladder Cancer, run by Paolo Puppo at 2 sites in Italy.
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 3 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: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate (time frame: One year). 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 NCT01004211, which also lists 3 linked publications.
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 17 Jan 2018.