Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06469229 |
| Other study ID # |
TRACE-UC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
June 2024 |
| Source |
Changhai Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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. We 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.
We anticipate that urine DNA methylation testing will show high sensitivity and specificity
for UC diagnosis in patients with hematuria, providing valuable non-invasive diagnostic
information and improving patient outcomes.
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.
We expect to demonstrate that urine DNA methylation testing, as a non-invasive diagnostic
method, has high sensitivity and specificity in diagnosis of UC in patients with hematuria.
This can provide clinicians with crucial reference information, reduce the diagnostic burden
on patients, and improve early detection rates and patient prognosis for UC.
