Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT04548193
Eligibility Criteria:
Inclusion Criteria:
* CANCER PATIENT: Age 18 years old or older (no upper limit)
* CANCER PATIENT: English speaking
* CANCER PATIENT: Diagnosed with stage Tis, Ta, or T1 bladder cancer
* CANCER PATIENT: Resides in the Western New York catchment area
* CANCER PATIENT: Did not receive a partial or radical cystectomy
* CANCER PATIENT: Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis
* CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis
* CANCER PATIENT: For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-current
* CANCER PATIENT: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
* PHYSICIAN: English speaking
* PHYSICIAN: Physician in a clinic located in the catchment area
* PHYSICIAN: Currently treats bladder cancer patients
Exclusion Criteria:
* CANCER PATIENT: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* CANCER PATIENT: Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* CANCER PATIENT: Adults unable to consent
* CANCER PATIENT: Adults unable to complete study measures in English
* CANCER PATIENT: Individuals who are not yet adults (infants, children, teenagers)
* CANCER PATIENT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* CANCER PATIENT: Unwilling or unable to follow protocol requirements
* PHYSICIAN: Unable to complete the study measures in English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04548193
Study Brief:
Protocol Section:
NCT04548193