Bladder CancerNCT05220189
PENK Methylation Test for Detecting Bladder Cancer
An observational study of Bladder Cancer and Hematuria; Benign, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bladder Cancer, Hematuria; Benign
- What is being tested?
- EarlyTect® Bladder Cancer test
- How many people
- 1,549 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hematuria
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
In Gab Jeong, MD PhD
About this study
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
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.
Read the 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.
- Conditions
- Bladder Cancer, Hematuria; Benign
- Being tested
- EarlyTect® Bladder Cancer test
- Keywords
- Bladder cancer, Hematuria, Methylation biomarker, EarlyTect® Bladder Cancer test, Real-time PCR (LTE-qMSP), Urine
- Medical subject headings
- Urinary Bladder Neoplasms, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlyTect® Bladder Cancer testDiagnostic test
A highly accurate and sensitive real-time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE-qMSP) for measuring PENK methylation in urine DNA to detect bladder cancer in hematuria patients.
| Study group | Role | What they receive |
|---|---|---|
| Hematuria patients aged ≥40 | Device: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR) Receives: Diagnostic Test: EarlyTect® Bladder Cancer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the EarlyTect® Bladder Cancer test
Sensitivity and specificity of the EarlyTect® Bladder Cancer test for detecting bladder cancer (Stages Ta high-grade and T1-T4) in patients with hematuria compared to the cystoscopy examination, both in terms of detecting bladder cancer. The reference method is the cystoscopic procedure, and lesions will be assessed histopathologically.
EarlyTect® Bladder Cancer test includes a measurement of PENK methylation and COL2A1 as a DNA control.
PENK methylation in urine DNA will be assessed quantitatively by Linear Target Enrichment-coupled Quantitative Methylation-Specific PCR (LTE-qMSP) using the Real-time PCR method. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive PENK methylation test/positive cystoscopy), Specificity = 100*(negative PENK methylation test/negative cystoscopy).
Measured: 1 year
Secondary outcomes (1)
The performance of the EarlyTect® Bladder Cancer test
The performance of the EarlyTect® Bladder Cancer test in detecting Bladder cancer in hematuria patients will be compared with those of the NMP22 and urine cytology tests.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start3 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,549 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Korea University Anam Hospital, National Cancer Center, Korea, Pusan National University Hospital, Samsung Medical Center, Ajou University School of Medicine, Ulsan University Hospital, Chonnam National University Hospital, Seoul Clinical Laboratories, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, In Gab Jeong, MD, Asan Medical Center
- Investigators
- Cheol Kwak, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220189
- Sponsor's protocol ID
- 2021-1626
- Status last verified
- Oct 2023
- First submitted
- 7 Jan 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. 2. Charpentier M, Gutierrez C, Guillaudeux T, Verhoest G, Pedeux R. Noninvasive urine-based tests to diagnose or detect recurrence of bladder cancer. Cancers. 2021;13:1650. 3. Freedman ND, Silverman DT, Hollenbeck AR, Schatzkin A, Abnet CC. Association between smoking and risk of bladder cancer among men and women. JAMA 2011; 306: 737-745. 4. Kitamura H, Kakehi Y. Treatment and management of high-grade T1 bladder cancer: what should we do after second TUR? Japanese Journal of Clinical Oncology. 2015;45(4):315-322. 5. Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M et al. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol. 2009;27(3):295-300. 6. Nepple KG, O'Donnell MA. The optimal management of T1 high-grade bladder cancer. Can Urol Assoc. 2009,3(suppl4):S188-92. 7. Wakui M, Shiigai T: Urinary tract cancer screening through analysis of urinary red blood cell volume distribution. Int J Urol. 2000,7(7):248-253. 8. Yafi FA, Aprikian AG, Tanguay S, Kassouf W. Patients with microscopic and gross hematuria: practice and referral patterns among primary care physicians in a universal health care system. Con Urol Assoc J. 2011;5(2):97-101. 9. Beukers W, Kandimalla R, van Houwelingen D, Kovacic H, Chin JF, Lingsma HF et al. The use of molecular analyses in voided urine for the assessment of patients with hematuria. PLOS One. 2013;8(10):e77657. 10. Chung W, Bondaruk J, Jelinek J, Lotan Y, Liang S, Czerniak B et al: Detection of bladder cancer using novel DNA methylation biomarkers in urine sediments. Cancer Epidemiol Biomarkers Prev. 2011,20(7):1483-91. 11. Oeyen E, Hoekx L, Wachter SD, Baldewijins M, Ameye F, Mertens I. Bladder cancer diagnosis and follow-up: The current status and possible role of extracellular vesicels. Mol. Sci. 2019;20(4),821 12. Sullivan PS, Chan JB, Levin MR, Rao J. Urine cytology and adjunct markers for detection and surveillance of bladder cancer. Am J Transl Res. 2010;2(4):412-40. 13. Soria, F, Droller MJ, Lotan Y, Gontero P, D'Andrea D, Gust KM et al. An up-to-date catalog of available urinary biomarkers for the surveillance of non-muscle invasive bladder cancer. World J Urol. 2018;36:1981-95. 14. Hajdijak T. UroVysion FISH test for detecting urothelial cancers: meta-analysis of diagnostic accuracy and comparison with urinary cytology testing. Urol Oncol 2008;26(6):646-51. 15. Mbeutcha A, Lucca I, Mathieu R, Lotan Y, Shariat SF. Current status of urinary biomarkers for detection and surveillance of bladder cancer. Urol Clin N AM 2016;43:47-62 16. Chung W, Bondaruk J, Jelinek J, Lotan Y, Liang S, Czerniak B, Lssa JPJ. Detection of bladder cancer using novel DNA methylation biomarkers in urine sediments. Cancer Epidermiol Biomarkers Prev. 2011;20(7):1483-91
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05220189
- Acronym / sponsor ID
- 2021-1626
- Conditions
- Bladder Cancer, Hematuria; Benign
- Keywords
- Bladder cancer, Hematuria, Methylation biomarker, EarlyTect® Bladder Cancer test, Real-time PCR (LTE-qMSP), Urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,549 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Korea University Anam Hospital, National Cancer Center, Korea, Pusan National University Hospital, Samsung Medical Center, Ajou University School of Medicine, Ulsan University Hospital, Chonnam National University Hospital, Seoul Clinical Laboratories, Seoul National University Bundang Hospital
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematuria patients aged ≥40 | – | Diagnostic Test: EarlyTect® Bladder Cancer testDevice: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hematuria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarlyTect® Bladder Cancer testA highly accurate and sensitive real-time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE-qMSP) for measuring PENK methylation in urine DNA to detect bladder cancer in hematuria patients. | Diagnostic test | Hematuria patients aged ≥40 |
Primary outcome
Sensitivity and specificity of the EarlyTect® Bladder Cancer test
Time frame: 1 year
Sensitivity and specificity of the EarlyTect® Bladder Cancer test for detecting bladder cancer (Stages Ta high-grade and T1-T4) in patients with hematuria compared to the cystoscopy examination, both in terms of detecting bladder cancer. The reference method is the cystoscopic procedure, and lesions will be assessed histopathologically. EarlyTect® Bladder Cancer test includes a measurement of PENK methylation and COL2A1 as a DNA control. PENK methylation in urine DNA will be assessed quantitatively by Linear Target Enrichment-coupled Quantitative Methylation-Specific PCR (LTE-qMSP) using the Real-time PCR method. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive PENK methylation test/positive cystoscopy), Specificity = 100*(negative PENK methylation test/negative cystoscopy).
1 secondary outcome
The performance of the EarlyTect® Bladder Cancer test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. 2. Charpentier M, Gutierrez C, Guillaudeux T, Verhoest G, Pedeux R. Noninvasive urine-based tests to diagnose or detect recurrence of bladder cancer. Cancers. 2021;13:1650. 3. Freedman ND, Silverman DT, Hollenbeck AR, Schatzkin A, Abnet CC. Association between smoking and risk of bladder cancer among men and women. JAMA 2011; 306: 737-745. 4. Kitamura H, Kakehi Y. Treatment and management of high-grade T1 bladder cancer: what should we do after second TUR? Japanese Journal of Clinical Oncology. 2015;45(4):315-322. 5. Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M et al. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol. 2009;27(3):295-300. 6. Nepple KG, O'Donnell MA. The optimal management of T1 high-grade bladder cancer. Can Urol Assoc. 2009,3(suppl4):S188-92. 7. Wakui M, Shiigai T: Urinary tract cancer screening through analysis of urinary red blood cell volume distribution. Int J Urol. 2000,7(7):248-253. 8. Yafi FA, Aprikian AG, Tanguay S, Kassouf W. Patients with microscopic and gross hematuria: practice and referral patterns among primary care physicians in a universal health care system. Con Urol Assoc J. 2011;5(2):97-101. 9. Beukers W, Kandimalla R, van Houwelingen D, Kovacic H, Chin JF, Lingsma HF et al. The use of molecular analyses in voided urine for the assessment of patients with hematuria. PLOS One. 2013;8(10):e77657. 10. Chung W, Bondaruk J, Jelinek J, Lotan Y, Liang S, Czerniak B et al: Detection of bladder cancer using novel DNA methylation biomarkers in urine sediments. Cancer Epidemiol Biomarkers Prev. 2011,20(7):1483-91. 11. Oeyen E, Hoekx L, Wachter SD, Baldewijins M, Ameye F, Mertens I. Bladder cancer diagnosis and follow-up: The current status and possible role of extracellular vesicels. Mol. Sci. 2019;20(4),821 12. Sullivan PS, Chan JB, Levin MR, Rao J. Urine cytology and adjunct markers for detection and surveillance of bladder cancer. Am J Transl Res. 2010;2(4):412-40. 13. Soria, F, Droller MJ, Lotan Y, Gontero P, D'Andrea D, Gust KM et al. An up-to-date catalog of available urinary biomarkers for the surveillance of non-muscle invasive bladder cancer. World J Urol. 2018;36:1981-95. 14. Hajdijak T. UroVysion FISH test for detecting urothelial cancers: meta-analysis of diagnostic accuracy and comparison with urinary cytology testing. Urol Oncol 2008;26(6):646-51. 15. Mbeutcha A, Lucca I, Mathieu R, Lotan Y, Shariat SF. Current status of urinary biomarkers for detection and surveillance of bladder cancer. Urol Clin N AM 2016;43:47-62 16. Chung W, Bondaruk J, Jelinek J, Lotan Y, Liang S, Czerniak B, Lssa JPJ. Detection of bladder cancer using novel DNA methylation biomarkers in urine sediments. Cancer Epidermiol Biomarkers Prev. 2011;20(7):1483-91
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Kwak, MD PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Hematuria; Benign, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheol Kwak, MD PhD (82-2-2072-0817, mdrafael@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the EarlyTect® Bladder Cancer test (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023; AzTrials last refreshed its copy on 28 Oct 2026.