PENK Methylation Test for Detecting Bladder Cancer

Last updated: October 1, 2023
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Nephropathy

Focal Segmental Glomerulosclerosis

Treatment

EarlyTect® Bladder Cancer test

Clinical Study ID

NCT05220189
2021-1626
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Individuals who agree to voluntarily sign an informed consent prior to the initiationof 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 monthafter consent

Exclusion

Exclusion Criteria:

  • Individuals who do not agree to voluntarily sign an informed consent prior to theinitiation 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 periodwithin the last 3 days
  • Subjects who have undergone invasive procedures in the urinary tract system within thelast 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 currentlyreceiving 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 precludeparticipation in the study

Study Design

Total Participants: 1549
Treatment Group(s): 1
Primary Treatment: EarlyTect® Bladder Cancer test
Phase:
Study Start date:
February 03, 2022
Estimated Completion Date:
January 31, 2024

Study 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.

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

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