Bladder Tumor (TURBT), Non-muscle Invasive Bladder Cancer (NMIBC)
Conditions
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.
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.
Interventions
PROCEDURECBI
CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean cells count before versus after liter 2 of CBI | 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 | 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 | 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 1 of CBI | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression rate of patients who underwent CBI post TURBT. | 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 |
| Recurrence rate of patients who underwent CBI post TURBT. | 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 |
Countries
United States
Outcome results
None listed