Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Washington
Study ID
NCT07225127
Status
Recruiting
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Conditions

  • Bladder Cancer
  • Non-muscle Invasive Bladder Cancer (NMIBC)
  • Recurrent Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Key Dates

Start date
Nov 3, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
408 participants (estimated)

Arms

  • Arm: Patients who have selected radical cystectomy
    Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
  • Arm: Patients who have selected bladder-sparing therapy
    Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
  • Arm: Caregivers of patients who have selected radical cystectomy
    Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
  • Arm: Caregivers of patients who have selected bladder-sparing therapy
    Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)

Primary Outcome Measure

Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST) [ Time Frame: 12 months after enrollment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612
Scott M Gilbert, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Francesca Nugent
[email protected]
319-467-5833
Kenneth G Nepple, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Angela Smith, MD, MS (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210-
Vanderbilt University Medical CenterNashvilleTennessee37232
Darlene Hancock
[email protected]
615-322-4063
Kristen Scarpato, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98195
Sung Min Kim
[email protected]
206-210-4040
John L Gore, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
H. Lee Moffitt Cancer Center & Research Institute· Tampa, FLUniversity of Iowa· Iowa City, IAUniversity of North Carolina· Chapel Hill, NCThe Ohio State University· Columbus, OHVanderbilt University Medical Center· Nashville, TNFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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