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Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

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ClinicalTrials.gov Identifier: NCT03839472
Recruitment Status : Suspended (Revision to improve cell recovery)
First Posted : February 15, 2019
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer (NMIBC) Bladder Tumor (TURBT) Procedure: CBI Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Continuous Bladder Irrigation (CBI)

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.

 Procedure: CBI
CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Recurrence rate of patients who underwent CBI post TURBT. [ Time Frame: 2 years after end of treatment ]

    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


  2. Progression rate of patients who underwent CBI post TURBT. [ Time Frame: 2 years after end of treatment ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
  • Primary bladder tumor occurrence

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839472


Locations
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United States, Ohio
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Lee Ponsky University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03839472    
Other Study ID Numbers: CASE12818
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases