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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03125460
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 40 years of age
* Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
* Subject is considered disease positive within 12 months (365 days) of enrollment.
* At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
* Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.
Exclusion
* Subject has been previously enrolled into the study.
* Urine specimen to be used for study purposes is from the first morning void.
* Subject has had an excision procedure within six weeks (42 days) of enrollment.
* The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT03125460
Study Brief:
Protocol Section:
NCT03125460