Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring

March 31, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer

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."

Study Overview

Status

Recruiting

Conditions

Detailed Description

The main research content of this project will be carried out from the following aspects: (1) Establish an exploratory cohort comprising patients with bladder cancer, patients with benign urological diseases, and healthy individuals. The exploratory cohort will be randomly divided into a training cohort and an internal validation cohort in a 2:1 ratio. Using the training cohort, a non-invasive detection method for bladder cancer based on CREPT expression in exfoliated urothelial cells will be developed, and a non-invasive diagnostic model for bladder cancer based on CREPT expression in exfoliated urothelial cells will be constructed. The diagnostic performance of the model will then be validated using the internal validation cohort; (2) Establish an external validation cohort including patients with bladder cancer, benign urological diseases, and healthy individuals to evaluate the clinical diagnostic performance of the model; (3) Enroll patients with bladder cancer undergoing follow-up cystoscopy after Transurethral Resection of Bladder Tumor (TURBT) and patients requiring repeat TURBT to establish a recurrence monitoring cohort, and evaluate the performance of this diagnostic model in predicting bladder cancer recurrence.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chaoyang District
      • Beijing, Chaoyang District, China, 100021
        • Recruiting
        • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Collect urine samples from patients diagnosed with or suspected of having bladder cancer. After urine collection, detect CREPT expression in exfoliated urothelial cells using immunocytochemistry, and perform conventional urinary cytology / FISH testing.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosed with or suspected of having bladder cancer.
After collecting 50 ml of the second morning urine, the expression of CREPT in urinary exfoliated cells was detected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination of the diagnostic model
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Xiongjun Ye, +86 13910380916

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC5785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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