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PENK Methylation Test for Detecting Bladder Cancer | Clinical Trials | Clareo Health

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PENK Methylation Test for Detecting Bladder Cancer

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

NCT05220189•Asan Medical Center

View on ClinicalTrials.gov

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.

Detailed Description

Patients with hematuria who are scheduled for cystoscopy will be asked to collect a urine sample for EarlyTect® Bladder Cancer test and will undergo NMP22 and urine cytology tests. The participants will undergo a cystoscopy within 30 days of enrollment. For confirmation of the diagnosis and stage of the tumor, representative histopathology slides from TURBT (Transurethral Resection of Bladder Tumors) may be retrieved and examined by the central pathology laboratory.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
•Subjects aged \<40 years
•Subjects with a history of bladder cancer and upper tract urothelial cancer
•Female who are currently menstruating or who have had their last menstrual period within the last 3 days
•Subjects who have undergone invasive procedures in the urinary tract system within the last 3 months
•Subjects with suspected upper urothelial cancer lesions on ultrasound or CT scan
•Subjects who have previously received pelvic radiation therapy
•Subjects who have been diagnosed with other cancers and have received or are currently receiving chemotherapy or immunotherapy within 6 months
•Subjects who require treatment for an active urinary tract infection or vaginitis
•Subjects undergoing prostate cancer treatment or requiring a prostate biopsy
+1 more criteria

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

February 3, 2022

Primary Completion Date

December 31, 2023

Completion Date

January 31, 2024

Last Updated

October 4, 2023

Enrollment

1,549

ESTIMATED participants

Conditions

Bladder CancerHematuria; Benign

Interventions

EarlyTect® Bladder Cancer test

DIAGNOSTIC_TEST

Contacts

Cheol Kwak, MD PhD

CONTACT

82-2-2072-0817 mdrafael@snu.ac.kr

In Gab Jeong, MD PhD

CONTACT

82-2-3010-5892 igjeong@amc.seoul.kr

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

NCT03375307

Advanced Bladder CarcinomaAdvanced Genitourinary System Carcinoma+4 more

View study

RECRUITING

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

NCT04235764

Bladder Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PENK Methylation Test for Detecting Bladder Cancer

Inclusion Criteria

Exclusion Criteria

Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)