CREPT urine test to diagnose and monitor bladder cancer
Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer
This project will test whether measuring CREPT levels in exfoliated urothelial cells from urine can help diagnose bladder cancer and detect recurrence in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Chaoyang District) |
| Trial ID | NCT07514897 on ClinicalTrials.gov |
What this trial studies
Investigators will develop a non-invasive diagnostic model based on CREPT expression measured in exfoliated urothelial cells from urine. An exploratory cohort of bladder cancer patients, patients with benign urological diseases, and healthy volunteers will be split 2:1 into a training set and an internal validation set to build and internally validate the model. An external validation cohort will then assess diagnostic performance, and a separate recurrence-monitoring cohort of patients undergoing follow-up or repeat TURBT will evaluate the model's ability to predict recurrence. The study aims for high sensitivity to overcome limitations of existing urine biomarkers and support integrated screening, diagnosis, and monitoring.
Who should consider this trial
Good fit: Adults aged 18–75 who are diagnosed with or suspected of having bladder cancer, patients undergoing follow-up after TURBT, and people with benign urologic conditions or healthy volunteers for comparison.
Not a fit: Patients with a history of other malignancies within five years, coexisting genitourinary tumors, non-standard or insufficient samples, or inability to comply with follow-up are less likely to benefit.
Why it matters
Potential benefit: If successful, the CREPT urine test could provide a highly sensitive, non-invasive way to detect bladder cancer and monitor for recurrence, potentially reducing the need for frequent invasive cystoscopies.
How similar studies have performed: CREPT-based urine testing is novel and has not been validated in large cohorts, although other urinary biomarkers for bladder cancer have shown mixed success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Patients diagnosed with or suspected of having bladder cancer; (2) Patients with benign urological diseases, including ureteral calculi, bladder calculi, cystitis, and ureteral stricture; (3) Consent to the use of experimental urine specimens and tissue specimens; (4) Aged 18 to 75 years; (5) Willing to sign informed consent, comply with the protocol, demonstrate good adherence, and cooperate with follow-up visits. Exclusion Criteria: * (1) History of other malignant tumors within 5 years or prior receipt of any anti-cancer treatment; (2) Urothelial carcinoma coexisting with other genitourinary tumors (e.g., renal cell carcinoma or prostate cancer); (3) Non-standard procedures for sample collection or storage; (4) Incomplete relevant information of the subject; (5) Patients with insufficient communication, comprehension, or cooperation, or poor compliance, who cannot guarantee completion of follow-up as required; (6) Subjects deemed by the investigator to be unsuitable for participation in this clinical trial for any other reasons, leading to withdrawal from the study.
Where this trial is running
Beijing, Chaoyang District
- National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Chaoyang District, China (Recruiting)
Study contacts
- Study coordinator: Xiongjun Ye
- Email: yexiongjun@cicams.cn
- Phone: +86 13910380916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.