Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
UMT-UC
1 other identifier
observational
1,500
0 countries
N/A
Brief Summary
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. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 8, 2025
April 1, 2025
1 year
April 2, 2025
April 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of DNA methylation test for urothelial carcinoma
Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer by calculating the sensitivity, specificity.
2 weeks
Interventions
The study aims to evaluate the diagnostic performance of the EPIPROBE TAGMe DNA Methylation Detection Kit for the detection of urothelial cancer. This assay utilizes targeted DNA methylation analysis to identify specific epigenetic alterations associated with urothelial malignancies. The performance of the kit will be assessed in terms of sensitivity, specificity, and overall diagnostic accuracy using clinical urine samples from a patient population with hematuria.
Eligibility Criteria
The initial population suspected of having urothelial carcinoma with hematuria
You may qualify if:
- Aged between 18 and 90 years, with gross or microscopic hematuria.
- Able to provide enough urine for testing before surgery.
- Consent to participate in the study and sign the informed consent form.
You may not qualify if:
- With history of any malignancies (including Urothelial carcinoma).
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Epiprobe Biotechnology Co., Ltd.lead
- Changhai Hospitalcollaborator
- RenJi Hospitalcollaborator
- Tongji Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
Biospecimen
Urine sediment DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2025
First Posted
April 6, 2025
Study Start
May 1, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share