Urine DNA Methylation Detection for Hematuria Evaluation

NCT06427993 | Not Yet Recruiting DMC

• 1 other identifier: CH_Hematuria_Metest
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Hematuria; Urothelial Carcinoma; Urine DNA Methylation

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of DNA methylation test

  Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the AUROC value.

  1 year

Secondary Outcomes (1)

• Sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers

  1 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 pilot 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 (\>3/HP).
• 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 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.
• \. Patients who did not undergo surgical treatment for various reasons. 6. Samples with insufficient DNA content or other quality control failures.

Sponsors & Collaborators

• Changhai Hospital: lead

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: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-05

Locations

CN (1)