Bladder CancerNCT05148728
Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors
A study testing Endoscopic fulguration in people with Bladder Cancer, run by Vall Hebron Insitut Recerca at 1 site in Spain.
Trial summary
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression. 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?
- Endoscopic fulguration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2021to 15 Mar 2024
- 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
- Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
- Accept cystoscopy surveillance
- Main lession less than 10mm
- Less than 7 lesions
- Negative or low grade cytology
- No solid aspect
Who cannot join
- previous High grade bladder cancer tumors
- previous Cis
- previous Upper Urinary Tract tumor
- previous pelvic radiotherapy
- hematuria
- meatal localisation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fernando Lozano Palacio
Barcelona, 08035
Fernando FL Lozano, MD, +34636244960, flozano@vhebron.net
About this study
Official title: Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.
Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.
This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.
This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
- Conditions
- Bladder Cancer
- Being tested
- Endoscopic fulguration
- Keywords
- active surveillance, fulguration, 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.
Endoscopic fulgurationProcedure or surgery
Also called Active surveillance
already included. WE will use Storz monopolar device for fulguration
| Study group | Role | What they receive |
|---|---|---|
| Active surveillance | No intervention | After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery |
| endoscopic fulguration | Active comparator | After a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode Receives: Procedure: Endoscopic fulguration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression rate
Number of patients that progress during the follow up
Measured: two years
Complications rate
Number and grade of complications in both arms. Clavien Dindo Scale will be used
Measured: two years
Secondary outcomes (2)
recurrence rate
number of recurrences
Measured: two years
quality of life measured with CAVICAVENMI questionnaire
quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall Hebron Insitut Recerca
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148728
- Sponsor's protocol ID
- PR(AG)401/2021
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: codified information (anonymous information)
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial in Low Grade Bladder Tumors: Active Surveillance vs Endoscopic Fulguration.
- ClinicalTrials.gov ID
- NCT05148728
- Acronym / sponsor ID
- PR(AG)401/2021
- Conditions
- Bladder Cancer
- Keywords
- active surveillance, fulguration, bladder cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vall Hebron Insitut RecercaResearch network
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 8 Dec 2021 (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.
Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.
Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.
This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.
This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | No intervention | –After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery |
| endoscopic fulguration | Active comparator | Procedure: Endoscopic fulgurationAfter a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
- Accept cystoscopy surveillance
- Main lession less than 10mm
- Less than 7 lesions
- Negative or low grade cytology
Key exclusion criteria (6 listed)
- previous High grade bladder cancer tumors
- previous Cis
- previous Upper Urinary Tract tumor
- previous pelvic radiotherapy
- hematuria
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 |
|---|---|---|
| Endoscopic fulgurationAlso: Active surveillancealready included. WE will use Storz monopolar device for fulguration | Procedure or surgery | endoscopic fulguration |
Primary outcome
Progression rate
Time frame: two years
Number of patients that progress during the follow up
Complications rate
Time frame: two years
Number and grade of complications in both arms. Clavien Dindo Scale will be used
2 secondary outcomes
recurrence rate
Time frame: two years
quality of life measured with CAVICAVENMI questionnaire
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Yes. codified information (anonymous information)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic fulguration in people with Bladder Cancer, run by Vall Hebron Insitut Recerca at 1 site in Spain.
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 6 inclusion and 6 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression rate (time frame: two years). The study lists 2 primary outcomes in all. 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 8 Dec 2021.