A study looking at a urine test combined with ultrasound to detect bladder cancer in people with blood in their urine
| ISRCTN | ISRCTN50547972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50547972 |
| Sponsor | The Second Affiliated Hospital of Jiaxing University |
| Funder | Science and Technology Bureau of Jiaxing City |
- Submission date
- 27/04/2026
- Registration date
- 27/04/2026
- Last edited
- 20/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Haematuria (blood in the urine) is a common symptom that can be a sign of bladder cancer. Currently, the standard way to diagnose bladder cancer is a procedure called cystoscopy, which involves inserting a camera into the bladder through the urethra. This test is invasive, uncomfortable, and expensive.
The aim of this study is to see whether a new urine test (called UroCAD), either on its own or combined with a simple ultrasound scan of the bladder, can accurately detect bladder cancer in people with haematuria. If successful, this non‑invasive approach might help some patients avoid unnecessary cystoscopies.
Who can participate?
Adults (aged 18 years or older) who have recurrent haematuria. This includes people with visible (gross) blood in the urine that comes and goes without pain, after kidney problems have been ruled out, and people with persistent microscopic blood in the urine (found on a urine test) for more than 6 months, after a urinary tract infection has been excluded.
What does the study involve?
Each participant will provide a one‑off morning urine sample (30–50 ml) for UroCAD testing. This test looks for certain DNA changes (chromosomal instability) in cells shed from the bladder lining. Participants will also have a standard bladder ultrasound scan. Finally, they will undergo a cystoscopy with biopsy or surgery to obtain tissue for a definite diagnosis (the reference standard). The study compares the results of the UroCAD test and the ultrasound with the tissue diagnosis to see how accurate the non‑invasive tests are.
What are the possible benefits and risks of participating?
There is no direct benefit to participants in this study, but the information gathered will help doctors develop better, less invasive tests for bladder cancer in the future.
Risks are very low. The urine test and ultrasound are painless and have no known health risks. Cystoscopy and biopsy are standard clinical procedures that carry a small risk of discomfort, bleeding, or urinary infection – these risks are the same for participants as for any patient undergoing these procedures outside the study.
Where is the study run from?
The study is led by the Department of Urology, the Second Affiliated Hospital of Jiaxing University, Jiaxing, China. It also involves several other hospitals in the Jiaxing area (the First People’s Hospital of Jiashan and the First People’s Hospital of Pinghu).
When is the study starting and how long is it expected to run for?
January 2024 to July 2025
Who is funding the study?
The study is funded by a grant from the Science and Technology Project Plan of Jiaxing (grant number 2024AY10005) (China)
Who is the main contact?
Dr Chenye Tang, john99233@126.com
Contact information
Public, Scientific, Principal investigator
Department of Urology, The Second Affiliated Hospital of Jiaxing University, 1518 North Huancheng Road
Jiaxing
314000
China
 ORCID ID |
0000-0001-8640-197X |
|---|---|
| Phone | +86 (0)13750781238 |
| john99233@126.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Prospective evaluation of UroCAD combined with ultrasonography for detecting bladder urothelial carcinoma in patients with hematuria |
| Study acronym | PECUS |
| Study objectives | To evaluate the diagnostic performance of urinary exfoliated‑cell chromosomal copy‑number aberration detection (UroCAD), alone and in combination with bladder ultrasonography, for detecting bladder urothelial carcinoma in patients presenting with hematuria, using histopathological examination as the reference standard. |
| Ethics approval(s) |
Approved 25/12/2023, Medical Ethics Committee of Second Affiliated Hospital of Jiaxing University (1518 North Huancheng Road, Jiaxing, 314000, China; +86 (0)573 82050475; jxeykjk1003@163.com), ref: 2023 ZFYJ 134 01 |
| Health condition(s) or problem(s) studied | Bladder urothelial carcinoma in patients presenting with hematuria |
| Methodology | This prospective observational diagnostic accuracy study consecutively enrolls adult patients presenting with recurrent hematuria. Participants provide a midstream first morning urine sample (30–50 ml) for UroCAD testing, which uses low‑coverage whole‑genome sequencing (LC‑WGS) to detect chromosomal instability (CIN) and genome‑wide copy‑number variation (CNV) profiles in exfoliated urothelial cells. All participants also undergo bladder ultrasonography, performed by radiologists blinded to the UroCAD results. The reference standard is histopathological examination of bladder tissue obtained via cystoscopy or surgical resection. The diagnostic performance of UroCAD alone, ultrasonography alone, and two prespecified combined rules (“CIN or ultrasound” and “CIN and ultrasound”) is evaluated using sensitivity, specificity, positive predictive value, negative predictive value, overall accuracy, and area under the receiver operating characteristic curve (AUC). Secondary analyses assess the association between CNV burden and tumor stage, as well as the discriminative ability of individual chromosomal arms. No randomisation or intervention allocation is applied. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 04/07/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Total final enrolment | 153 |
| Key inclusion criteria | 1. Age ≥18 years 2. Recurrent hematuria, including either: 2.1. Intermittent, painless, gross hematuria after renal causes have been ruled out by nephrology consultation; or 2.2. Persistent microscopic hematuria for >6 months confirmed by urinalysis, following exclusion of urinary tract infection 3. Able to provide a midstream first-morning urine sample (30–50 mL) for UroCAD testing 4. Willing and able to undergo cystoscopy and histopathological examination (or surgical resection for pathological confirmation) as the reference standard 5. Provide written informed consent to participate |
| Key exclusion criteria | 1. Unwillingness to provide a urine sample 2. Refusal to participate or inability to provide informed consent 3. Prior history of other non-urothelial malignancies 4. Incomplete clinical records |
| Date of first enrolment | 14/01/2024 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/07/2026 | 20/07/2026 | Yes | No |
Editorial Notes
20/07/2026: Publication reference added.
27/04/2026: Study's existence confirmed by the Medical Ethics Committee of Second Affiliated Hospital of Jiaxing University
