HematuriaNCT06469229
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria
An observational study of Hematuria and Urothelial Carcinoma, run by Changhai Hospital at 1 site in China.
Trial summary
Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hematuria, Urothelial Carcinoma, Bladder Cancer
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective multicenter cohort study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria.
Who may be able to join
- Aged between 18 and 99 years, with gross or microscopic hematuria (RBC ≥ 3 /HPF or RBC > 18 /μL for men, > 33 /μL for women).
- Able to provide 50ml urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Who cannot join
- With history of any malignancies (including UC).
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy.
- Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- Patients who did not undergo surgical treatment for various reasons.
- Samples with insufficient DNA content or other quality control failures.
- Incomplete clinical or pathological data.
- Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria: a Prospective, Multicenter Cohort Study
Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection.
Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. This study also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients.
Read more
For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status.
Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited).
Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples.
Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports.
Urine DNA methylation testing is expected to demonstrate high sensitivity and specificity for diagnosing urothelial carcinoma (UC) in patients with hematuria. This non-invasive diagnostic method promises to deliver valuable information, potentially leading to improved patient outcomes.
Read the detailed description
Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria.
All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria.
Based on the expected performance indicators of urine DNA methylation testing and previous study data, the sample size calculation is as follows:
Expected sensitivity: 0.86 Hypothesized sensitivity: 0.80 Expected specificity: 0.90 Hypothesized specificity: 0.85 Significance level (Alpha): 0.05 Considering a dropout rate of 5%, the actual number of participants to be recruited is 1109, ensuring an effective sample size of 1053.
Study Procedure Enrollment and Sample Collection: Screen patients meeting the inclusion criteria, obtain informed consent, collect urine samples, and assign screening numbers. Authorized researchers will perform blinding and aliquoting of the enrolled samples to ensure objectivity and impartiality in the testing process. After blinding, perform urine DNA methylation testing according to the test reagent instructions.
To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.
Follow-up:
For UC patients: Evaluate the relationship between preoperative urine DNA methylation levels and postoperative recurrence-free survival, progression-free survival, and overall prognosis.
Clinical Trial Report Each center will compile a clinical summary and submit it to the main center. The main center will consolidate the reports from all centers, draft, and publish the final clinical trial report.
It is anticipated that urine DNA methylation testing will demonstrate high sensitivity and specificity as a non-invasive diagnostic method for detecting urothelial carcinoma (UC) in patients with hematuria. This approach can provide clinicians with crucial reference information, reduce the diagnostic burden on patients, and enhance early detection rates and patient prognosis for UC.
- Keywords
- Hematuria, Urothelial Carcinoma, Urine DNA Methylation, Multicenter
- Medical subject headings
- Hematuria, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Ureteral Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of DNA methylation test in patients with hematuria
Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the sensitivity, specificity.
Measured: 2 weeks
Secondary outcomes (5)
Other diagnostic performance of DNA methylation test in patients with hematuria
Calculate the Positive predictive value, negative predictive value，Diagnostic accuracy and the AUROC value of DNA methylation biomarkers.
Measured: 2 weeks
Comparing the diagnostic performance of of urine DNA methylation and urine cytology
Comparing the sensitivity and specificity of urine DNA methylation and urine cytology for the diagnosis of UC in patients with hematuria.
Measured: 2 weeks
The diagnosis effectiveness of urine DNA methylation test in different types of pathological characteristics of UC
Calculate the detection rate of urine DNA methylation test at different tumor grades, invasion depth, tumor size, and tumor number of UC patients
Measured: 2 weeks
UC patients follow-up
Evaluate the relationship between preoperative urine DNA methylation levels and postoperative progression-free survival in UC patients.
Measured: 2 year
Non-UC patients follow-up
Evaluate the relationship between preoperative urine DNA methylation status and the risk of developing urothelial carcinoma within one year in patients diagnosed as non-UC.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, First Hospital of China Medical University, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469229
- Sponsor's protocol ID
- TRACE-UC
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria: a Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06469229
- Acronym / sponsor ID
- TRACE-UC
- Keywords
- Hematuria, Urothelial Carcinoma, Urine DNA Methylation, Multicenter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, First Hospital of China Medical University, Tongji Hospital
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jun 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.
Background Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection.
Objectives To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC in patients with hematuria, using standard clinical and pathological diagnoses as the gold standard. This study also aim to investigate the association between preoperative urine DNA methylation status and prognosis in UC patients.
For non-UC patients: Follow up for one year to assess the risk of UC development based on preoperative urine DNA methylation status.
Sample Size Calculation Expected sensitivity: 86% Expected specificity: 90% Significance level (Alpha): 0.05 Total participants needed: 1053 (adjusted for 5% dropout rate, 1109 participants will be recruited).
Study Procedure Enrollment and Sample Collection: Screen patients, obtain consent, collect urine samples.
Blinding and Testing: Blinded sample processing and DNA methylation testing. Unblinding and Analysis: Statistical analysis of sensitivity and specificity. Reporting: Compilation and consolidation of clinical trial reports.
Urine DNA methylation testing is expected to demonstrate high sensitivity and specificity for diagnosing urothelial carcinoma (UC) in patients with hematuria. This non-invasive diagnostic method promises to deliver valuable information, potentially leading to improved patient outcomes.
Detailed description
Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria.
All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria.
Based on the expected performance indicators of urine DNA methylation testing and previous study data, the sample size calculation is as follows:
Expected sensitivity: 0.86 Hypothesized sensitivity: 0.80 Expected specificity: 0.90 Hypothesized specificity: 0.85 Significance level (Alpha): 0.05 Considering a dropout rate of 5%, the actual number of participants to be recruited is 1109, ensuring an effective sample size of 1053.
Study Procedure Enrollment and Sample Collection: Screen patients meeting the inclusion criteria, obtain informed consent, collect urine samples, and assign screening numbers. Authorized researchers will perform blinding and aliquoting of the enrolled samples to ensure objectivity and impartiality in the testing process. After blinding, perform urine DNA methylation testing according to the test reagent instructions.
To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.
Follow-up:
For UC patients: Evaluate the relationship between preoperative urine DNA methylation levels and postoperative recurrence-free survival, progression-free survival, and overall prognosis.
Clinical Trial Report Each center will compile a clinical summary and submit it to the main center. The main center will consolidate the reports from all centers, draft, and publish the final clinical trial report.
It is anticipated that urine DNA methylation testing will demonstrate high sensitivity and specificity as a non-invasive diagnostic method for detecting urothelial carcinoma (UC) in patients with hematuria. This approach can provide clinicians with crucial reference information, reduce the diagnostic burden on patients, and enhance early detection rates and patient prognosis for UC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective multicenter cohort study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria.
Key inclusion criteria (3 listed)
- Aged between 18 and 99 years, with gross or microscopic hematuria (RBC ≥ 3 /HPF or RBC > 18 /μL for men, > 33 /μL for women).
- Able to provide 50ml urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Key exclusion criteria (8 listed)
- With history of any malignancies (including UC).
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy.
- Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- Patients who did not undergo surgical treatment for various reasons.
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
Diagnostic performance of DNA methylation test in patients with hematuria
Time frame: 2 weeks
Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the sensitivity, specificity.
5 secondary outcomes
Other diagnostic performance of DNA methylation test in patients with hematuria
Time frame: 2 weeks
Comparing the diagnostic performance of of urine DNA methylation and urine cytology
Time frame: 2 weeks
The diagnosis effectiveness of urine DNA methylation test in different types of pathological characteristics of UC
Time frame: 2 weeks
UC patients follow-up
Time frame: 2 year
Non-UC patients follow-up
Time frame: 2 year
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 5 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Hematuria
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Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population
UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Recruiting
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
Hematuria - Cause Not Known
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.
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 Hematuria and Urothelial Carcinoma, run by Changhai 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Jul 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?
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 performance of DNA methylation test in patients with hematuria (time frame: 2 weeks). 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 5 Jul 2024.