Clinical trial · Observational
Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring
Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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."
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with or suspected of having bladder cancer.
- description
- After collecting 50 ml of the second morning urine, the expression of CREPT in urinary exfoliated cells was detected.
Primary outcomes (1)
- measure
- Discrimination of the diagnostic model
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTLi J, Deng Z, Soerensen SJC, Kachuri L, Cardenas A, Graff RE, Leppert JT, Langston ME, Chung BI. Ambient air pollution and urological cancer risk: A systematic review and meta-analysis of epidemiological evidence. Nat Commun. 2024 Jun 15;15(1):5116. doi: 10.1038/s41467-024-48857-2. PMID 38879581