Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469229
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria a Prospective Multicenter Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 005 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
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 005 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 086 Hypothesized sensitivity 080 Expected specificity 090 Hypothesized specificity 085 Significance level Alpha 005 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
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 086 Hypothesized sensitivity 080 Expected specificity 090 Hypothesized specificity 085 Significance level Alpha 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None