Urine Methylation Markers for Bladder Cancer

Overseen By Alireza Ghoreifinejadian, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Unwilling to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the diagnosis and monitoring of upper tract urothelial cancer (UTUC) by studying DNA markers in urine. Researchers seek to determine if these markers can better predict the risk and early recurrence of cancer compared to traditional methods like urine cell tests and biopsies. The trial employs the Femto Human DNA Quantification Kit to analyze urine samples at various intervals. Individuals with a primary diagnosis of UTUC might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance cancer detection and monitoring.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for measuring DNA markers in urine?

A previous study used the Femto Human DNA Quantification Kit to accurately detect and measure small amounts of DNA, including human DNA. This test can identify tiny pieces of DNA in urine samples. The study aims to determine if this kit is safe and effective for detecting DNA markers related to upper tract urothelial cancer, a type of bladder cancer. No evidence of harmful side effects has been found from using the kit. Since the kit does not involve drugs or treatments, it does not cause typical medication side effects. Its primary focus is safely measuring DNA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Femto Human DNA Quantification Kit because it offers a non-invasive approach to monitoring bladder cancer through urine samples. Unlike traditional methods that often rely on more invasive procedures like cystoscopy or imaging, this kit measures DNA methylation markers in urine, which could simplify and speed up detection. This method has the potential to provide earlier and more frequent monitoring of disease progression, making it a promising tool for improving patient care.

What evidence suggests that this method is effective for diagnosing and predicting upper tract urothelial cancer?

Research shows that identifying specific DNA markers in urine can reliably diagnose bladder and upper urinary tract cancers. Previous studies demonstrated that urine tests targeting multiple DNA markers detect these cancers with over 90% accuracy, confirming the presence of cancer effectively. In this trial, researchers will quantify urine DNA samples from patients with primary UTUC using the Femto Human DNA Quantification Kit at baseline, 3 months, and 6 months. Additionally, using urine for testing, known as a liquid biopsy, offers a non-invasive way to check for cancer markers, making it easier and more comfortable for patients. This method holds promise for assessing cancer risks and predicting early cancer recurrence. ^{2 3 4 6 7}

Who Is on the Research Team?

Michael Abern, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients with upper tract urothelial cancer (UTUC) who are scheduled for surgery. It aims to find DNA markers in urine that could help diagnose UTUC, assess risk, and predict the cancer's return after treatment.

Inclusion Criteria

My cancer is in the upper part of my urinary tract.

Exclusion Criteria

Patients who do not understand and/or are unwilling to sign a written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Urine DNA markers are measured before surgery to improve diagnosis and assess risk

1 week

1 visit (in-person)

Follow-up

Participants are monitored for early recurrence of cancer through urine DNA marker analysis

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Femto Human DNA Quantification Kit

Trial Overview The study is testing the Femto Human DNA Quantification Kit on urine samples from UTUC patients. These samples will be compared to traditional diagnostic methods like urine cell analysis and tissue biopsy.

How Is the Trial Designed?

Group I: Patients with primary UTUC (upper tract urothelial carcinoma) Experimental Treatment 1 Intervention

Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. withpower.com withpower.com/trial/phase-upper-tract-urothelial-cancer-1-2025-4b5a6

Urine Methylation Markers for Bladder Cancer This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06805630/urine-methylation-markers-in-utuc

Urine Methylation Markers in UTUC This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059345/

Clinical evaluation of Bladder CARE, a new epigenetic test ... In this study we test the feasibility of a simple, sensitive, and non-invasive detection of BC using Bladder CARE test in urine samples.

4. sciencedirect.com sciencedirect.com/science/article/pii/S075333222300817X

Liquid biopsy in urothelial carcinoma: Detection techniques ... Liquid biopsy is an accurate method of determining the molecular profile of UC and is a cutting-edge and popular technique that is expected to complement ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10949661/

Clinical effectiveness of a multitarget urine DNA test for ... Simultaneous identification of both bladder and upper urinary tract tumors was enabled with sensitivities exceeding 90%. No significant ...

6. zymoresearch.com zymoresearch.com/products/femto-human-dna-quantification-kit?srsltid=AfmBOoofPKGsVgIeGsAHiLULASv8bL6A_8EccoaOXjDFKfc75x2f6WQY

Femto Human DNA Quantification Kit Femto DNA Quantification Kits accurately detect and quantify human, bacterial, and fungal DNA from as little as 20 fg of DNA input. Buy Now. Overview

7. molecular.abbott molecular.abbott/us/en/products/oncology/urovysion-bladder-cancer-kit

UroVysion Bladder Cancer Kit The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus.