Clinical trial NCT05220189: PENK Methylation Test for Detecting Bladder Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Hematuria; Benign
Keywords: Bladder cancer
Hematuria
Methylation biomarker
EarlyTect® Bladder Cancer test
Real-time PCR (LTE-qMSP)
Urine
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Korea University Anam Hospital
name: National Cancer Center, Korea
name: Pusan National University Hospital
name: Samsung Medical Center
name: Ajou University School of Medicine
name: Ulsan University Hospital
name: Chonnam National University Hospital
name: Seoul Clinical Laboratories
name: Seoul National University Bundang Hospital
First posted: 2022-02-02
Enrollment: 1549
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematuria

Brief 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 criteria: 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
* Subject has any condition which, in the opinion of the investigator should preclude participation in the study

Primary outcomes:
measure: Sensitivity and specificity of the EarlyTect® Bladder Cancer test
timeFrame: 1 year
Secondary outcomes:
measure: The performance of the EarlyTect® Bladder Cancer test
timeFrame: 1 year
Other outcomes:
measure: Comparison of clinical sensitivity and specificity to the NMP22 test
timeFrame: 1 year
measure: Comparison of clinical sensitivity and specificity to the urine cytology test
timeFrame: 1 year
measure: Sensitivity of EarlyTect® Bladder Cancer test for detecting bladder cancer with stages CIS and Ta low-grade
timeFrame: 1 year
measure: Positive predictive value (PPV) and Negative predictive value (NPV)
timeFrame: 1 year
measure: Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and NMP22 tests
timeFrame: 1 year
measure: Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and cytology tests
timeFrame: 1 year
measure: Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer, NMP22, and cytology tests
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Cheol Kwak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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