CREPT urine test to diagnose and monitor bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.