Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Observational
Started
2026-03-01
Last updated
2026-04-07
Condition(s) studied
Bladder Cancer
Study summary
This study will, for the first time, establish a non-invasive diagnostic model for bladder cancer based on CREPT expression levels in exfoliated urothelial cells using a multicenter cohort, and validate its value in the non-invasive diagnosis and recurrence monitoring of bladder cancer. Its high sensitivity is expected to overcome the technical limitations of existing biomarkers and provide an innovative solution for establishing an integrated precision diagnosis and treatment system encompassing "screening, diagnosis, and monitoring."
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Discrimination of the diagnostic model — Short-term follow-up for 6 months, with follow-ups conducted at 3 months and 6 months post-enrollment; long-term follow-up for 1 year, with an additional follow-up at 12 months post-enrollment. In the internal validation of the exploratory cohort and the external validation cohort, calculate the AUC, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the diagnostic model, using "pathological diagnosis results" as the gold standard, to validate the model's ability to distinguish between "bladder cancer" and "non-bladder cancer (benign diseases + healthy individuals)". Among these, an AUC ≥ 0.85 in the external validation cohort is the primary indicator.
Trial sites (1)
Facility
City
Region
Status
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Chaoyang District
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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