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

Trial Summary

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 data supports the effectiveness of the treatment Femto Human DNA Quantification Kit for bladder cancer?

The research suggests that detecting changes in DNA methylation (a chemical change to DNA that can affect gene activity) in urine can help identify bladder cancer early and assess its progression. This supports the idea that using a urine-based DNA methylation test, like the Femto Human DNA Quantification Kit, could be effective for non-invasive bladder cancer diagnosis and monitoring. ^{1 2 3 4 5}

Is the urine methylation marker test for bladder cancer safe for humans?

The research articles focus on the development and performance of urine-based DNA methylation tests for detecting bladder cancer, but they do not provide specific safety data for humans. These tests are non-invasive, as they use urine samples, which are generally safe to collect. ^{2 3 4 6 7}

How does the urine methylation marker treatment for bladder cancer differ from other treatments?

This treatment is unique because it uses a non-invasive urine test to detect DNA methylation markers specific to bladder cancer, allowing for early detection and monitoring of the disease without the need for invasive procedures like cystoscopy. It offers higher sensitivity and specificity compared to traditional urine cytology and FISH tests, especially in detecting early-stage and minimal tumors. ^{2 3 4 8 9}

What is the purpose of this trial?

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 visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Zymo/Pangea Research Corporation for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.

Research Team

Michael Abern, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Urine DNA samples will be quantified using the Femto Human DNA Quantification Kit at baseline, 3 months, and 6 months.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Methylation of a novel panel of tumor suppressor genes in urine moves forward noninvasive diagnosis and prognosis of bladder cancer: a 2-center prospective study. [2013]

2. England pubmed.ncbi.nlm.nih.gov

A methylation assay for the detection of non-muscle-invasive bladder cancer (NMIBC) recurrences in voided urine. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Increase sensitivity in detecting superficial, low grade bladder cancer by combination analysis of hypermethylation of E-cadherin, p16, p14, RASSF1A genes in urine. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Improved Noninvasive Bladder Cancer Diagnosis using Urine Sediments and Novel DNA Methylation Biomarker Panels. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Versatile Assay for Detection of Aberrant DNA Methylation in Bladder Cancer. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

DNA-Methylation-Based Detection of Urological Cancer in Urine: Overview of Biomarkers and Considerations on Biomarker Design, Source of DNA, and Detection Technologies. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A novel and sensitive DNA methylation marker for the urine-based liquid biopsies to detect bladder cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer. [2021]