. 2023 Nov 18;23:1127. doi: 10.1186/s12885-023-11605-8

Table 1.

The CISTO Study inclusion and exclusion criteria

Inclusion Criteria	Exclusion Criteria
1. Adult 18 years of age or older; and 2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with: a. Pathology documentation from any hospital/clinic/medical center, and b. More than 50% urothelial carcinoma component in the specimen; and 3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and 4. Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and 5. 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	1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation); 2. Previous history of cystectomy or radiation therapy for bladder cancer; 3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer; 4. Any history of upper tract urothelial carcinoma; 5. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening; 6. Contraindication to radical cystectomy (e.g., ASA classification of 4, cancer does not warrant consideration of cystectomy); 7. Contraindication to medical therapy (i.e., intolerant of all medical therapies); 8. Unable to provide written informed consent in English; 9. Unable to be contacted for research surveys; 10. Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC (unless in the control/comparator arm of a Phase II trial) or any blinded interventional trial for NMIBC

Inclusion Criteria

Exclusion Criteria

1. Adult 18 years of age or older; and

2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:

a. Pathology documentation from any hospital/clinic/medical center, and

b. More than 50% urothelial carcinoma component in the specimen; and

3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and

4. Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and

5. 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

1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);

2. Previous history of cystectomy or radiation therapy for bladder cancer;

3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;

4. Any history of upper tract urothelial carcinoma;

5. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;

6. Contraindication to radical cystectomy (e.g., ASA classification of 4, cancer does not warrant consideration of cystectomy);

7. Contraindication to medical therapy (i.e., intolerant of all medical therapies);

8. Unable to provide written informed consent in English;

9. Unable to be contacted for research surveys;

10. Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC (unless in the control/comparator arm of a Phase II trial) or any blinded interventional trial for NMIBC

NMIBC Non-muscle invasive bladder cancer, BCG Bacillus Calmette-Guérin, ASA American Society of Anesthesiologists