Bladder CancerNCT03066310
Urine-DNA Biomarkers in Detecting Bladder Cancer
An observational study of Bladder Cancer and Biomarker, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Biomarker, Diagnosis
- What is being tested?
- Next generation sequencing
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2017to 10 Jan 2020
- 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
- Adult, Older adult
Study population: The patients diagnosed with suspected bladder cancer in Xiangya Hospital of Central South University from February of 2017 till the end of this study.
Who may be able to join
- patients with gross hematuria or other clinical sympton suspected of bladder cancer.
- male or female patients aged >= 18 years.
- available tumor tissue, urine and blood sample.
- signed informed consent form.
Who cannot join
- prior diagnosis of cancer except bladder cancer
- age under 18 years
- individuals unwilling to sign the IRB-approved consent form
- comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South Univeristy
Changsha, Hunan, 410008
About this study
Official title: Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA
DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.
Read the detailed description
Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. Voided urine samples will be collected prior to cystoscopy. Cell free DNA and cellular DNA will both be extracted and analyzed. A blood sample will be taken. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. Next generation sequencing will be applied and hotspots mutations in DNA from urine, blood and tumor. Logistic regression was used to analyze the association between predictor variables and bladder cancer. The investigators will confirm a couple of common mutations occured in urine-DNA and blood-derived DNA simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. Moreover, external consistency test will be performed on subsequent patients collection.
- Conditions
- Bladder Cancer, Biomarker, Diagnosis, Urine
- Being tested
- Next generation sequencing
- Keywords
- Bladder cancer, Urine, DNA biomarker, Diagnosis
- Medical subject headings
- Urinary Bladder Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation sequencingDiagnostic test
The obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed Urinary Bladder Cancers | Patients who are being monitored for bladder cancer will be the experimental group to test the urine-DNA by next generation sequencing for bladder cancer biomarkers Receives: Diagnostic Test: Next generation sequencing | |
| Non-Urinary Bladder Cancers | Patients being treated for gross hematuria will provide a negative control to provide data from testing by next generation sequencing for biomarkers in patients being treated for other diseases. Receives: Diagnostic Test: Next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of urinalysis by Urine-DNA test
number of patients "declared positive" with the Urine-DNA test among the patients actually suffering from bladder carcinoma
Measured: through study completion, an average of 8 months
specificity of urinalysis by Urine-DNA test
number of patients "declared negative" with the Urine-DNA test among the patients without bladder carcinoma
Measured: through study completion, an average of 8 months
Identification of positive urine-DNA test results with the next generation sequencing
Identification of presence of positive urine-DNA test results with the designed panel.
Measured: through study completion, an average of 8 months
Identification of urine-DNA mutations with the next generation sequencing to create an diagnosis algorithm.
Identification of presence or absence of the mutations in urine-DNA with the next generation sequencing to create an idiagnosis algorithm
Measured: through study completion, an average of 8 months
Secondary outcomes (4)
sensitivity of blood DNA test
number of patients "declared positive" with the blood-DNA test among the patients actually suffering from bladder carcinoma
Measured: through study completion, an average of 8 months
specificity of blood DNA test
number of patients "declared negative" with the blood DNA test among the patients without bladder carcinoma
Measured: through study completion, an average of 8 months
comparison of the sensitivity of the urine DNA versus blood DNA test
number of patients "declared positive" with the urine DNA test versus patients "declared positive" with the blood DNA test.
Measured: through study completion, an average of 8 months
comparison of the specificity of the urine DNA versus blood DNA test
number of patients "declared negative" with the urine DNA test versus patients "declared negative" with the blood DNA test.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start17 Jan 2017
- Primary completion5 Jan 2020
- Study completion10 Jan 2020
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 Xiangya Hospital of Central South UniversityThe 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
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Cancer Hospital, Hunan Provincial People's Hospital, Second People's Hospital of Hunan
- Responsible party
- Sponsor
- Investigators
- Long Wang, M.D., Ph.D, Study chair, Xiangya Hospital of Central South Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066310
- Sponsor's protocol ID
- XYURO002
- Status last verified
- Jan 2020
- First submitted
- 20 Feb 2017
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA
- ClinicalTrials.gov ID
- NCT03066310
- Acronym / sponsor ID
- XYURO002
- Conditions
- Bladder Cancer, Biomarker, Diagnosis, Urine
- Keywords
- Bladder cancer, Urine, DNA biomarker, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Cancer Hospital, Hunan Provincial People's Hospital, Second People's Hospital of Hunan
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 28 Feb 2017 (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.
DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.
Detailed description
Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. Voided urine samples will be collected prior to cystoscopy. Cell free DNA and cellular DNA will both be extracted and analyzed. A blood sample will be taken. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. Next generation sequencing will be applied and hotspots mutations in DNA from urine, blood and tumor. Logistic regression was used to analyze the association between predictor variables and bladder cancer. The investigators will confirm a couple of common mutations occured in urine-DNA and blood-derived DNA simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. Moreover, external consistency test will be performed on subsequent patients collection.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Urinary Bladder Cancers | – | Diagnostic Test: Next generation sequencingPatients who are being monitored for bladder cancer will be the experimental group to test the urine-DNA by next generation sequencing for bladder cancer biomarkers |
| Non-Urinary Bladder Cancers | – | Diagnostic Test: Next generation sequencingPatients being treated for gross hematuria will provide a negative control to provide data from testing by next generation sequencing for biomarkers in patients being treated for other diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients diagnosed with suspected bladder cancer in Xiangya Hospital of Central South University from February of 2017 till the end of this study.
Key inclusion criteria (4 listed)
- patients with gross hematuria or other clinical sympton suspected of bladder cancer.
- male or female patients aged >= 18 years.
- available tumor tissue, urine and blood sample.
- signed informed consent form.
Key exclusion criteria (4 listed)
- prior diagnosis of cancer except bladder cancer
- age under 18 years
- individuals unwilling to sign the IRB-approved consent form
- comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.
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 |
|---|---|---|
| Next generation sequencingThe obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm. | Diagnostic test | Diagnosed Urinary Bladder Cancers, Non-Urinary Bladder Cancers |
Primary outcome
sensitivity of urinalysis by Urine-DNA test
Time frame: through study completion, an average of 8 months
number of patients "declared positive" with the Urine-DNA test among the patients actually suffering from bladder carcinoma
specificity of urinalysis by Urine-DNA test
Time frame: through study completion, an average of 8 months
number of patients "declared negative" with the Urine-DNA test among the patients without bladder carcinoma
Identification of positive urine-DNA test results with the next generation sequencing
Time frame: through study completion, an average of 8 months
Identification of presence of positive urine-DNA test results with the designed panel.
Identification of urine-DNA mutations with the next generation sequencing to create an diagnosis algorithm.
Time frame: through study completion, an average of 8 months
Identification of presence or absence of the mutations in urine-DNA with the next generation sequencing to create an idiagnosis algorithm
4 secondary outcomes
sensitivity of blood DNA test
Time frame: through study completion, an average of 8 months
specificity of blood DNA test
Time frame: through study completion, an average of 8 months
comparison of the sensitivity of the urine DNA versus blood DNA test
Time frame: through study completion, an average of 8 months
comparison of the specificity of the urine DNA versus blood DNA test
Time frame: through study completion, an average of 8 months
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 10 Nov 2022.
- 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. This study is not recruiting at the moment.
Long Wang, M.D., Ph.D study chair
Xiangya Hospital of Central South Univeristy
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 Biomarker, run by Xiangya Hospital of Central South University 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 4 inclusion and 4 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 10 Nov 2022. 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?
sensitivity of urinalysis by Urine-DNA test (time frame: through study completion, an average of 8 months). The study lists 4 primary outcomes in all. 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 10 Nov 2022.