HematuriaNCT06427993
Urine DNA Methylation Detection for Hematuria Evaluation
An observational study of Hematuria and Urothelial Carcinoma, run by Changhai Hospital at 1 site in China.
Trial summary
Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. 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
- 71 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 31 Dec 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective pilot 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 (>3/HP).
- 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 malignancy or concomitant malignancies other than UC.
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy. 4 Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- 5. Patients who did not undergo surgical treatment for various reasons. 6. Samples with insufficient DNA content or other quality control failures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine Exfoliated Cell DNA Methylation Detection for Urothelial Carcinomas Diagnosis in Patients With Hematuria--A Prospective, Single-center, Cohort Study
Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients.
Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria.
Read more
Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves.
Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.
Read the detailed description
- Background Hematuria is a common symptom of urinary system diseases and can be caused by various factors, including infection, stones, trauma, and tumors. Urothelial carcinoma (UC) is the most common malignant tumor of the urinary system, primarily occurring in the bladder, renal pelvis, and ureter. The early symptoms of UC are often not obvious, with hematuria being the most common symptom. However, current diagnostic methods such as urine cytology and cystoscopy have limitations in sensitivity and specificity for diagnosing UC. Additionally, cystoscopy is invasive and can cause discomfort for patients. DNA methylation biomarkers have shown potential in detecting UC, providing a non-invasive method to improve diagnostic sensitivity and specificity, especially in patients with hematuria.
- Objective This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. By collecting preoperative urine samples from a small cohort of hematuria patients and performing DNA methylation testing, we aim to explore the feasibility and advantages of this method in clinical applications.
- Methods Study Design: This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. Sample Size Calculation: Based on our previous observations, the incidence of urothelial carcinoma in patients with hematuria is 20%-30%, slightly higher than reported in other literature. Therefore, we hypothesize that 25% of the patients in the hematuria cohort have UC. The group allocation ratio (R): N-/N+ = 75%/25% = 3. Assumptions: Area under the curve (AUC) under H0: 0.5 AUC under H1: 0.8 Power: 0.95 Significance level (Alpha): 0.05 Type of data: Continuous FPR range: 0.00 to 1.00 Results: Using PASS 15.0 software for sample size calculation to ensure sufficient statistical power. The calculated sample size is: N+ (number of patients with UC): 14 N- (number of patients without UC): 42 Total sample size (N): 56 Considering a 20% dropout rate, the adjusted sample size is: N+': 18 N-': 53 Total sample size (N'): 71 Inclusion and Exclusion Criteria: Inclusion Criteria: Aged between 18 and 99 years, with gross or microscopic hematuria (>3/HP). Able to provide 50ml urine for testing before surgery. Consent to participate in the study and sign the informed consent form. Exclusion Criteria: With history of malignancy or concomitant malignancies other than 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. Sample Collection: Clinicians will collect fresh urine samples from enrolled hematuria patients and record their basic information, clinical information, and medical history. Samples will be randomly numbered and provided to DNA methylation testing personnel to ensure blinding. Testing Method: Urine samples were collected in EP Genomic DNA Kit with an automated nucleic acid extraction instrument. Subsequently, 100 ng of genomic DNA was used for methylation-sensitive restriction enzyme qPCR (MSRE-qPCR) detection as described previously. Different from bisulfite PCR relying on bisulfite conversion, MSRE-qPCR is based on the selective digestion of DNA by methylation-sensitive enzyme followed by qPCR with primers that surround the cutting site. Unblinding and Data Organization: After the last sample is successfully enrolled and tested, non-recruiting personnel and testing personnel will unblind the samples and organize clinical and pathological information. Data Analysis: Using pathological results as the gold standard. Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers. Use statistical methods (such as ROC curves) to evaluate the diagnostic performance of DNA methylation biomarkers and calculate the AUROC. Ethics and Informed Consent: This study has been approved by the hospital's ethics committee, and all participants must sign an informed consent form.
- Conclusion This study aims to validate the effectiveness of urine DNA methylation testing in detecting urothelial carcinoma in patients with hematuria and provide evidence for its clinical application. The results of this preliminary study will offer essential data support and design optimization suggestions for future larger-scale studies.
- Keywords
- Hematuria, Urothelial Carcinoma, Urine DNA Methylation
- 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
Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the AUROC value.
Measured: 1 year
Secondary outcomes (1)
Sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers
Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427993
- Sponsor's protocol ID
- CH_Hematuria_Metest
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Exfoliated Cell DNA Methylation Detection for Urothelial Carcinomas Diagnosis in Patients With Hematuria--A Prospective, Single-center, Cohort Study
- ClinicalTrials.gov ID
- NCT06427993
- Acronym / sponsor ID
- CH_Hematuria_Metest
- Keywords
- Hematuria, Urothelial Carcinoma, Urine DNA Methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 May 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: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients.
Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria.
Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves.
Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies.
Detailed description
- Background Hematuria is a common symptom of urinary system diseases and can be caused by various factors, including infection, stones, trauma, and tumors. Urothelial carcinoma (UC) is the most common malignant tumor of the urinary system, primarily occurring in the bladder, renal pelvis, and ureter. The early symptoms of UC are often not obvious, with hematuria being the most common symptom. However, current diagnostic methods such as urine cytology and cystoscopy have limitations in sensitivity and specificity for diagnosing UC. Additionally, cystoscopy is invasive and can cause discomfort for patients. DNA methylation biomarkers have shown potential in detecting UC, providing a non-invasive method to improve diagnostic sensitivity and specificity, especially in patients with hematuria.
- Objective This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. By collecting preoperative urine samples from a small cohort of hematuria patients and performing DNA methylation testing, we aim to explore the feasibility and advantages of this method in clinical applications.
- Methods Study Design: This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. Sample Size Calculation: Based on our previous observations, the incidence of urothelial carcinoma in patients with hematuria is 20%-30%, slightly higher than reported in other literature. Therefore, we hypothesize that 25% of the patients in the hematuria cohort have UC. The group allocation ratio (R): N-/N+ = 75%/25% = 3. Assumptions: Area under the curve (AUC) under H0: 0.5 AUC under H1: 0.8 Power: 0.95 Significance level (Alpha): 0.05 Type of data: Continuous FPR range: 0.00 to 1.00 Results: Using PASS 15.0 software for sample size calculation to ensure sufficient statistical power. The calculated sample size is: N+ (number of patients with UC): 14 N- (number of patients without UC): 42 Total sample size (N): 56 Considering a 20% dropout rate, the adjusted sample size is: N+': 18 N-': 53 Total sample size (N'): 71 Inclusion and Exclusion Criteria: Inclusion Criteria: Aged between 18 and 99 years, with gross or microscopic hematuria (>3/HP). Able to provide 50ml urine for testing before surgery. Consent to participate in the study and sign the informed consent form. Exclusion Criteria: With history of malignancy or concomitant malignancies other than 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. Sample Collection: Clinicians will collect fresh urine samples from enrolled hematuria patients and record their basic information, clinical information, and medical history. Samples will be randomly numbered and provided to DNA methylation testing personnel to ensure blinding. Testing Method: Urine samples were collected in EP Genomic DNA Kit with an automated nucleic acid extraction instrument. Subsequently, 100 ng of genomic DNA was used for methylation-sensitive restriction enzyme qPCR (MSRE-qPCR) detection as described previously. Different from bisulfite PCR relying on bisulfite conversion, MSRE-qPCR is based on the selective digestion of DNA by methylation-sensitive enzyme followed by qPCR with primers that surround the cutting site. Unblinding and Data Organization: After the last sample is successfully enrolled and tested, non-recruiting personnel and testing personnel will unblind the samples and organize clinical and pathological information. Data Analysis: Using pathological results as the gold standard. Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers. Use statistical methods (such as ROC curves) to evaluate the diagnostic performance of DNA methylation biomarkers and calculate the AUROC. Ethics and Informed Consent: This study has been approved by the hospital's ethics committee, and all participants must sign an informed consent form.
- Conclusion This study aims to validate the effectiveness of urine DNA methylation testing in detecting urothelial carcinoma in patients with hematuria and provide evidence for its clinical application. The results of this preliminary study will offer essential data support and design optimization suggestions for future larger-scale studies.
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 pilot 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 (>3/HP).
- Able to provide 50ml urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
Key exclusion criteria (4 listed)
- With history of malignancy or concomitant malignancies other than UC.
- Severe urinary tract infection leading to sepsis.
- Patients with indwelling catheters, nephrostomy, or cystostomy. 4 Severe liver or kidney failure or other conditions deemed unsuitable for the study.
- 5. Patients who did not undergo surgical treatment for various reasons. 6. Samples with insufficient DNA content or other quality control failures.
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
Time frame: 1 year
Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the AUROC value.
1 secondary outcome
Sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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. 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 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 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: status not confirmed, as of the sponsor's last update on 20 Jun 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?
Results are not available in the source record.
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 (time frame: 1 year). 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 20 Jun 2024.