Non-muscle Invasive Bladder Cancer (NMIBC)NCT03839472
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
A study testing CBI in people with Non-muscle Invasive Bladder Cancer (NMIBC) and Bladder Tumor (TURBT), run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC), Bladder Tumor (TURBT)
- What is being tested?
- CBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to Dec 2022
- 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
- Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
- Primary bladder tumor occurrence
Who cannot join
- Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease
- Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI
- Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team
- Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy
- History of previous pelvic radiation
- Bladder tumor volume > 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured.
Read the detailed description
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.
- Being tested
- CBI
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBIProcedure or surgery
CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Bladder Irrigation (CBI) | Experimental | Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure.
Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples. Receives: Procedure: CBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean cells count before versus after liter 1 of CBI
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Measured: Immediately after CBI procedure.
Change in mean cells count before versus after liter 2 of CBI
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Measured: Immediately after CBI procedure.
Change in mean cells count before versus after liter 3 of CBI
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Measured: Immediately after CBI procedure.
Change in mean cells count before versus after liter 4 of CBI
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Measured: Immediately after CBI procedure.
Change in mean cells count before versus after liter 5 of CBI
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Measured: Immediately after CBI procedure.
Secondary outcomes (2)
Recurrence rate of patients who underwent CBI post TURBT.
Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Recurrence is defined as the identification of a recurrent tumor of same grade and or stage or lower
Measured: 2 years after end of treatment
Progression rate of patients who underwent CBI post TURBT.
Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Progression is defined as a recurrent tumor of higher grade and or stage
Measured: 2 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Sep 2019
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Revision to improve cell recovery
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Ponsky, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839472
- Sponsor's protocol ID
- CASE12818
- Status last verified
- May 2022
- First submitted
- 8 Feb 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
- ClinicalTrials.gov ID
- NCT03839472
- Acronym / sponsor ID
- CASE12818
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Revision to improve cell recovery
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Feb 2019 (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.
The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured.
Detailed description
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
| Arm | Type | Receives |
|---|---|---|
| Continuous Bladder Irrigation (CBI) | Experimental | Procedure: CBIEach subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure. Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
- Primary bladder tumor occurrence
Key exclusion criteria (6 listed)
- Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease
- Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI
- Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team
- Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy
- History of previous pelvic radiation
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 |
|---|---|---|
| CBICBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure. | Procedure or surgery | Continuous Bladder Irrigation (CBI) |
Primary outcome
Change in mean cells count before versus after liter 1 of CBI
Time frame: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 2 of CBI
Time frame: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 3 of CBI
Time frame: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 4 of CBI
Time frame: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Change in mean cells count before versus after liter 5 of CBI
Time frame: Immediately after CBI procedure.
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
2 secondary outcomes
Recurrence rate of patients who underwent CBI post TURBT.
Time frame: 2 years after end of treatment
Progression rate of patients who underwent CBI post TURBT.
Time frame: 2 years after end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
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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.
Lee Ponsky principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI in people with Non-muscle Invasive Bladder Cancer (NMIBC) and Bladder Tumor (TURBT), run by Case Comprehensive Cancer Center at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 11 May 2022. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in mean cells count before versus after liter 1 of CBI (time frame: Immediately after CBI procedure.). The study lists 5 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 11 May 2022.