A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® Bladder Cancer test for bladder cancer among patients with hematuria by comparing it to the results of cystoscopy examinations. The second objective is to compare the clinical performance of EarlyTect® Bladder Cancer test with a NMP22 test and urine cytology test with respect to bladder cancer. By histopathological examination, lesions identified during cystoscopy will be confirmed as malignant or non-malignant by histological examination.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening

• Adults aged ≥40

• Subjects who have had gross or microscopic hematuria within the 3 months

• Subjects who had no history of bladder cancer and upper tract urothelial cancer

• Subjects who will undergo cystoscopy, NMP22 test, and urine cytology within 1 month after consent

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Cheol Kwak, MD PhD
mdrafael@snu.ac.kr
82-2-2072-0817
Backup
In Gab Jeong, MD PhD
igjeong@amc.seoul.kr
82-2-3010-5892
Time Frame
Start Date: 2022-02-03
Estimated Completion Date: 2024-01-31
Participants
Target number of participants: 1549
Treatments
Hematuria patients aged ≥40
Device: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR)
Related Therapeutic Areas
Endoscopy
Bladder Cancer
Sponsors
Collaborators: Seoul National University Bundang Hospital, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Ajou University School of Medicine, Seoul Clinical Laboratories, Pusan National University Hospital, Ulsan University Hospital, Korea University Anam Hospital, National Cancer Center, Korea
Leads: Asan Medical Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)

The Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multicenter Clinical Study (Truce-LB02)

Enrollment Status: Recruiting
Publish Date: September 25, 2025
Intervention Type: Diagnostic test
Study Phase: Not Applicable

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

Enrollment Status: Recruiting
Publish Date: June 08, 2025

A Multicenter, Single-blind, Observational Clinical Trial of URISAFE

A Multicenter, Single-blind, Observational Clinical Trial of URISAFE

Enrollment Status: Recruiting
Publish Date: February 13, 2025
Intervention Type: Diagnostic test, Procedure
View All