Bladder CancerNCT07514897
Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring
An observational study of Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 1 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Chaoyang District, 100021
Xiongjun Ye, +86 13910380916, yexiongjun@cicams.cn
About this study
Official title: 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."
Read the 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.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Discrimination of the diagnostic model
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiongjun Ye, Study chair, +86 13910380916
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514897
- Sponsor's protocol ID
- NCC5785
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li 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.
PubMed 38879581
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of CREPT Expression in Exfoliated Urothelial Cells for Early Diagnosis and Recurrence Monitoring of Bladder Cancer
- ClinicalTrials.gov ID
- NCT07514897
- Acronym / sponsor ID
- NCC5785
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 38879581Li 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.
- A biomedical research paper cited in this dissertation for theoretical support and literature review.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiongjun Ye study chair
+86 13910380916
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiongjun Ye (+86 13910380916, yexiongjun@cicams.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07514897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.