Bladder CancerNCT06193941
Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits
An observational study of Bladder Cancer and Urothelial Carcinoma, run by Zhongnan Hospital at 1 site in China.
Trial summary
Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma
- What is being tested?
- RT-qPCR
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University
Who may be able to join
- Age ≥ 18 years with defined gender;
- Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.
Who cannot join
- Aged <18 years;
- Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
- History of other malignant tumors
- Specimens with hemolytic conditions;
- Patients with incomplete, undocumented, and uncooperative data.
Trial locations and contacts
1 site in 1 country.
About this study
Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.
Read the detailed description
In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Being tested
- RT-qPCR
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-qPCRDiagnostic test
RT-qPCR
| Study group | Role | What they receive |
|---|---|---|
| Case group （bladder cancer） | Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. Receives: Diagnostic Test: RT-qPCR | |
| Control group （benigh） | Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. Receives: Diagnostic Test: RT-qPCR | |
| Healthy people group | Urine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. Receives: Diagnostic Test: RT-qPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-qPCR
Urine exosomal RNA
Measured: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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.
- 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fubing Wang, Doctor, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193941
- Sponsor's protocol ID
- W20231218
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits
- ClinicalTrials.gov ID
- NCT06193941
- Acronym / sponsor ID
- W20231218
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jan 2024 (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 the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.
Detailed description
In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group （bladder cancer） | – | Diagnostic Test: RT-qPCRUrine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. |
| Control group （benigh） | – | Diagnostic Test: RT-qPCRUrine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. |
| Healthy people group | – | Diagnostic Test: RT-qPCRUrine exosomes were enriched for RT-qPCR within 4 hours after samples were collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University
Key inclusion criteria (2 listed)
- Age ≥ 18 years with defined gender;
- Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.
Key exclusion criteria (5 listed)
- Aged <18 years;
- Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
- History of other malignant tumors
- Specimens with hemolytic conditions;
- Patients with incomplete, undocumented, and uncooperative data.
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 |
|---|---|---|
| RT-qPCRRT-qPCR | Diagnostic test | Case group （bladder cancer）, Control group （benigh）, Healthy people group |
Primary outcome
RT-qPCR
Time frame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.
Urine exosomal RNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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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. This study is not recruiting at the moment.
Fubing Wang, Doctor principal investigator
Wuhan University
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 and Urothelial Carcinoma, run by Zhongnan Hospital 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 2 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
RT-qPCR (time frame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.). 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 9 Jan 2024.