Bladder CancerCISTO2NCT07225127
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
An observational study of Bladder Cancer and Recurrent Bladder Cancer, run by University of Washington at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Recurrent Bladder Cancer, Non-muscle Invasive Bladder Cancer (NMIBC)
- How many people
- 408 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Nov 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with a diagnosis of recurrent high-grade NMIBC who are considering their next treatment will be approached for participation in this observational study in addition to their caregivers.
Who may be able to join
- Adult 18 years of age or older; and
- Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
- Pathology documentation from any hospital/clinic/medical center
- More than 50% urothelial carcinoma component in the specimen; and
- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
- In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
Who cannot join
- Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
- Previous history of cystectomy or radiation therapy for bladder cancer;
- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
- Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;
- Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled);
- Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity);
Show all 10Show fewer
- Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies);
- Unable to provide written informed consent in English;
- Unable to be contacted for research surveys;
- Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Adrian Gerstel, 919-475-6720, Adrian_Gerstel@med.unc.edu
Angela Smith, MD, MS
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Helena Gastier, 614-257-3434, Helena.Gastier@osumc.edu
Akshay Sood, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Francesca Nugent, 319-467-5833, francesca-nugent@uiowa.edu
Kenneth G Nepple, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Darlene Hancock, 615-322-4063, darlene.hancock@vumc.org
Kristen Scarpato, MD
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98195
Sung Min Kim, 206-210-4040, cistorc@uw.edu
John L Gore, MD, MS
- Recruiting
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Hannah DeCosta, 813-745-3216, hannah.decosta@moffitt.org
Scott M Gilbert, MD
About this study
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).
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have selected radical cystectomy | Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy | |
| Patients who have selected bladder-sparing therapy | Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST) | |
| Caregivers of patients who have selected radical cystectomy | Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Measured: 12 months after enrollment
Secondary outcomes (15)
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
Patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Measured: 24 months after enrollment
Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST)
Caregiver-reported financial toxicity is measured by the COST measure. The questionnaire consists of 12 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
Measured: 12 months after enrollment
Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Patient-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.
Measured: 12 months after enrollment
Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Caregiver-reported financial well-being is measured by the CFPB financial well-being scale. The scale consists of 10 items plus 2 questions to assist with scoring. Total response values are converted into an overall financial well-being score between 0 to 100, with higher scores indicating better financial wellness. The financial well-being scores vary based on age and how the questionnaire was administered.
Measured: 12 months after enrollment
Caregiver self-reported quality of life as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQol)
Caregiver-reported quality of life is measured by the CarGOQol questionnaire. The CarGOQol consists of 29 items, with 5-point Likert response scales, covering 10 domains. The scores for each domain are obtained by calculating the average item score for that domain. The overall score is calculated as the average of the domain scores. A domain score is calculated when more than half of the questions are answered. All domain scores and the overall score are linearly transformed and moralized using a scale of 0 to 100. Higher scores indicate better quality of life for the caregiver.
Measured: 12 months after enrollment
Patient-reported quality of life as measured by the Physical Function scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items to be calculated.
Measured: 12 months after enrollment
Patient self-reported urinary health as measured by the Bladder Cancer Index urinary summary score
Patient-reported urinary health is measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 12 months after enrollment
Patient-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
Patient-reported anxiety is measured by the PROMIS Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Patient-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Patient-reported depression is measured by the PROMIS Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Caregiver-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
Caregiver-reported anxiety is measured by the PROMIS Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Caregiver-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Caregiver-reported depression is measured by the PROMIS Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L
Patient-reported generic quality of life is measured by the EQ-5D. Scores range from 0 to 1, with higher scores indicating better health.
Measured: 12 months after enrollment
Caregiver-reported generic quality of life as measured by the EuroQoL EQ-5D-5L
Caregiver-reported generic quality of life is measured by the EQ-5D. Scores range from 0 to 1, with higher scores indicating better health.
Measured: 12 months after enrollment
Patient progression-free survival
The evaluation of the effect of treatment choice on progression-free survival. Survival times are calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastasis or death). A progression is defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurs at the last electronic health record review or death.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient bladder cancer-specific survival
The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times are calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurs at the last electronic health record review or date of death from bladder cancer.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start3 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (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.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John Gore, University of Washington
- Investigators
- John L Gore, MD, MS, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225127
- Sponsor's protocol ID
- RG1126118
- Other IDs
- R01CA289268
- Acronym
- CISTO2
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
- ClinicalTrials.gov ID
- NCT07225127
- Acronym / sponsor ID
- CISTO2 / RG1126118
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Nov 2025 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who have selected radical cystectomy | – | –Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy |
| Patients who have selected bladder-sparing therapy | – | –Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST) |
| Caregivers of patients who have selected radical cystectomy | – | –Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of recurrent high-grade NMIBC who are considering their next treatment will be approached for participation in this observational study in addition to their caregivers.
Key inclusion criteria (6 listed)
- Adult 18 years of age or older; and
- Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
- In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
Key exclusion criteria (10 listed)
- Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
- Previous history of cystectomy or radiation therapy for bladder cancer;
- Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
- Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;
- Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
Time frame: 12 months after enrollment
The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
15 secondary outcomes
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
Time frame: 24 months after enrollment
Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST)
Time frame: 12 months after enrollment
Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Time frame: 12 months after enrollment
Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale
Time frame: 12 months after enrollment
Caregiver self-reported quality of life as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQol)
Time frame: 12 months after enrollment
Patient-reported quality of life as measured by the Physical Function scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
Time frame: 12 months after enrollment
Patient self-reported urinary health as measured by the Bladder Cancer Index urinary summary score
Time frame: 12 months after enrollment
Patient-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
Time frame: 12 months after enrollment
Patient-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Time frame: 12 months after enrollment
Caregiver-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
Time frame: 12 months after enrollment
Caregiver-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Time frame: 12 months after enrollment
Patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L
Time frame: 12 months after enrollment
Caregiver-reported generic quality of life as measured by the EuroQoL EQ-5D-5L
Time frame: 12 months after enrollment
Patient progression-free survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient bladder cancer-specific survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
John L Gore, MD, MS principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Recurrent Bladder Cancer, run by University of Washington at 6 sites 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung Min Kim (206-210-4040, cistorc@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST) (time frame: 12 months after enrollment). 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 21 Oct 2026.