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:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT05889195
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who are referred to urology and are either scheduled for a cystoscopy or have had a cystoscopic investigation within the last two months for the evaluation of hematuria meeting ONE of the following criteria:
EITHER: (a) Microscopic hematuria, confirmed by urine microscopy of three or more RBC/HPF (or equivalent). OR: (b) Gross hematuria.
2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
3. Able to give informed, written consent.
4. Able and willing to comply with study requirements (complete at-home urine sampling, fill in test request forms (TRFs) / tube labels and ship urine back to the central laboratory using a prepaid courier service).
5. Aged 18 years or older.
Footnotes:
1. For the microscopic hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder. ii) Patients who are considered high risk by the AUA 2020 guidelines.
2. For gross hematuria patients, the recruitment priority at each respective site will be: i) Patients who have undergone initial diagnostic cystoscopy and have been scheduled for a later TURBT for suspicious lesion in the bladder
Exclusion Criteria:
1. Prior history of bladder malignancy.
2. Reported Cxbladder results within the last six months.
3. Prior history of upper tract urothelial carcinoma (UC) or prostatic urethral UC.
4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch).
5. Subjects aged 89 years of age or older.
6. Subjects with a history of pelvic radiation.
7. Subjects currently receiving systemic chemotherapy or has had systemic chemotherapy within the last six weeks.
8. Subjects with renal failure on dialysis.
9. History of schistosomiasis.
10. Subjects who have had intervention (TURBT, diathermia, etc.,) following a previous cystoscopy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05889195
Study Brief:
Protocol Section:
NCT05889195