Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

NCT06469229 | Not Yet Recruiting

• 1 other identifier: TRACE-UC
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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): 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.

Conditions

Hematuria; Urothelial Carcinoma; Bladder Cancer; Ureter Cancer; Renal Pelvis Cancer

Keywords

Hematuria; Urothelial Carcinoma; Urine DNA Methylation; Multicenter

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of DNA methylation test in patients with hematuria

  Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the sensitivity, specificity.

  2 weeks

Secondary Outcomes (5)

• Other diagnostic performance of DNA methylation test in patients with hematuria

  2 weeks

• Comparing the diagnostic performance of of urine DNA methylation and urine cytology

  2 weeks

• The diagnosis effectiveness of urine DNA methylation test in different types of pathological characteristics of UC

  2 weeks

• UC patients follow-up

  2 year

• Non-UC patients follow-up

  2 year

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• RenJi Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine sediment DNA

MeSH Terms

Conditions

Hematuria; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Ureteral Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)