Bladder CancerNCT07735858
Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer
An observational study of Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Bladder cancer is one of the most common malignancies of the urinary system and is characterized by high recurrence rates and poor long-term outcomes. Early detection and accurate diagnosis are essential for improving clinical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Liquid biopsy
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to Sep 2027
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Bladder cancer or other urinary diseases and healthy individuals
Who may be able to join
- 1. Age ≥18 years.
- 2. Patients with bladder cancer confirmed by pathological examination.
- 3. Patients with benign urological diseases confirmed by clinical evaluation.
- 4. Ability to provide urine samples and relevant clinical information.
- 5. Written informed consent provided.
Who cannot join
- 1. History of other malignant tumors, except participants specifically included in the validation cohort.
- 2. Severe organ dysfunction.
- 3. Glomerulonephritis.
- 4. Recent significant urinary tract injury.
- 5. Inadequate urine sample availability.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Development and Prospective Validation of a Precision Diagnostic Model for Bladder Cancer Based on Microfluidic Isolation and Multiplex Detection of Urinary Exosomes
Bladder cancer is one of the most common malignancies of the urinary system and is characterized by high recurrence rates and poor long-term outcomes. Early detection and accurate diagnosis are essential for improving clinical management.
This prospective diagnostic accuracy study aims to develop and validate a precision diagnostic model for bladder cancer based on microfluidic isolation and multiplex detection of urinary exosomes.
Read more
A novel microfluidic platform will be developed for rapid and efficient urinary exosome enrichment. Multi-omics approaches, including RNA sequencing and proteomic profiling, will be used to identify bladder cancer-associated urinary exosome biomarkers. A multiplex microfluidic detection chip will subsequently be developed for simultaneous detection of multiple biomarkers.
A diagnostic model integrating urinary exosome biomarker profiles and clinical characteristics will be developed in a training cohort and prospectively validated in an independent cohort. Diagnostic performance will be evaluated using pathological diagnosis as the reference standard.
This study aims to establish a non-invasive, rapid, and accurate diagnostic strategy for bladder cancer.
Read the detailed description
This study aims to establish and validate a urinary exosome-based diagnostic model for bladder cancer using microfluidic technologies.
The study consists of four stages:
First, a novel microfluidic urinary exosome isolation platform will be developed using magnetic stirring-assisted resuspension and tangential flow washing technologies to improve exosome recovery efficiency.
Second, bladder cancer-associated urinary exosome biomarkers will be identified using transcriptomic and proteomic approaches. Candidate nucleic acid and protein biomarkers will be screened and validated.
Third, a multiplex microfluidic detection chip will be developed to enable simultaneous detection of multiple urinary exosome-derived biomarkers.
Fourth, a diagnostic model integrating biomarker expression profiles and clinical characteristics will be constructed in a training cohort and prospectively validated in an independent cohort.
Pathological diagnosis will serve as the reference standard for evaluating diagnostic performance.
- Conditions
- Bladder Cancer
- Being tested
- Liquid biopsy
- 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.
Liquid biopsyDiagnostic test
Liquid biopsy
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Cohort | Participants with pathologically confirmed bladder cancer, including non-muscle-invasive bladder cancer (Ta and T1) and muscle-invasive bladder cancer (≥T2). Receives: Diagnostic Test: Liquid biopsy | |
| Benign Urological Disease Control Cohort | Participants diagnosed with benign urological diseases without evidence of malignancy. Receives: Diagnostic Test: Liquid biopsy | |
| Other Urological Malignancy Cohort | Participants with other urinary system malignancies included for evaluation of diagnostic specificity during the validation phase. Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of urinary exosome-based model for bladder cancer detection
The primary outcome is the diagnostic performance of the urinary exosome-based model compared with pathological diagnosis as the reference standard.
Measured: At completion of prospective validation (September 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University, Beijing Proteome Research Center
- Responsible party
- Principal investigator, Xiongjun Ye, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735858
- Sponsor's protocol ID
- NCC5508
- Other IDs
- 25/4165362
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Prospective Validation of a Precision Diagnostic Model for Bladder Cancer Based on Microfluidic Isolation and Multiplex Detection of Urinary Exosomes
- ClinicalTrials.gov ID
- NCT07735858
- Acronym / sponsor ID
- NCC5508
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Tsinghua University, Beijing Proteome Research Center
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jul 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.
Bladder cancer is one of the most common malignancies of the urinary system and is characterized by high recurrence rates and poor long-term outcomes. Early detection and accurate diagnosis are essential for improving clinical management.
This prospective diagnostic accuracy study aims to develop and validate a precision diagnostic model for bladder cancer based on microfluidic isolation and multiplex detection of urinary exosomes.
A novel microfluidic platform will be developed for rapid and efficient urinary exosome enrichment. Multi-omics approaches, including RNA sequencing and proteomic profiling, will be used to identify bladder cancer-associated urinary exosome biomarkers. A multiplex microfluidic detection chip will subsequently be developed for simultaneous detection of multiple biomarkers.
A diagnostic model integrating urinary exosome biomarker profiles and clinical characteristics will be developed in a training cohort and prospectively validated in an independent cohort. Diagnostic performance will be evaluated using pathological diagnosis as the reference standard.
This study aims to establish a non-invasive, rapid, and accurate diagnostic strategy for bladder cancer.
Detailed description
This study aims to establish and validate a urinary exosome-based diagnostic model for bladder cancer using microfluidic technologies.
The study consists of four stages:
First, a novel microfluidic urinary exosome isolation platform will be developed using magnetic stirring-assisted resuspension and tangential flow washing technologies to improve exosome recovery efficiency.
Second, bladder cancer-associated urinary exosome biomarkers will be identified using transcriptomic and proteomic approaches. Candidate nucleic acid and protein biomarkers will be screened and validated.
Third, a multiplex microfluidic detection chip will be developed to enable simultaneous detection of multiple urinary exosome-derived biomarkers.
Fourth, a diagnostic model integrating biomarker expression profiles and clinical characteristics will be constructed in a training cohort and prospectively validated in an independent cohort.
Pathological diagnosis will serve as the reference standard for evaluating diagnostic performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Cohort | – | Diagnostic Test: Liquid biopsyParticipants with pathologically confirmed bladder cancer, including non-muscle-invasive bladder cancer (Ta and T1) and muscle-invasive bladder cancer (≥T2). |
| Benign Urological Disease Control Cohort | – | Diagnostic Test: Liquid biopsyParticipants diagnosed with benign urological diseases without evidence of malignancy. |
| Other Urological Malignancy Cohort | – | Diagnostic Test: Liquid biopsyParticipants with other urinary system malignancies included for evaluation of diagnostic specificity during the validation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Bladder cancer or other urinary diseases and healthy individuals
Key inclusion criteria (5 listed)
- 1. Age ≥18 years.
- 2. Patients with bladder cancer confirmed by pathological examination.
- 3. Patients with benign urological diseases confirmed by clinical evaluation.
- 4. Ability to provide urine samples and relevant clinical information.
- 5. Written informed consent provided.
Key exclusion criteria (5 listed)
- 1. History of other malignant tumors, except participants specifically included in the validation cohort.
- 2. Severe organ dysfunction.
- 3. Glomerulonephritis.
- 4. Recent significant urinary tract injury.
- 5. Inadequate urine sample availability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid biopsyLiquid biopsy | Diagnostic test | Benign Urological Disease Control Cohort, Bladder Cancer Cohort, Other Urological Malignancy Cohort |
Primary outcome
Diagnostic accuracy of urinary exosome-based model for bladder cancer detection
Time frame: At completion of prospective validation (September 2027)
The primary outcome is the diagnostic performance of the urinary exosome-based model compared with pathological diagnosis as the reference standard.
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 30 Jul 2026.
Related trials for Bladder Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
Bladder Cancer
RecruitingPhase 3
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intermediate Risk Non-Muscle Invasive Bladder Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of urinary exosome-based model for bladder cancer detection (time frame: At completion of prospective validation (September 2027)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.