Urine-DNA Biomarkers in Detecting Bladder Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-17

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Performance Evaluation of Urine DNA Methylation Testing for the Detection of Urothelial Carcinoma in Patients With Hematuria

NCT06469229

Hematuria Urothelial Carcinoma Bladder Cancer +2 more

NOT_YET_RECRUITING

ctDNA in Subjects With Muscle-invasive Bladder Cancer Treated With Trimodality Therapy

NCT05630131

Bladder Cancer Muscle-Invasive Bladder Carcinoma

COMPLETED

Urine Methylation Markers in UTUC

NCT06805630

Upper Tract Urothelial Cancer

RECRUITING NA

Urine DNA Methylation Detection for Hematuria Evaluation

NCT06427993

Hematuria Urothelial Carcinoma Bladder Cancer +2 more

NOT_YET_RECRUITING

Multi Institutional Study in Patient Presenting With Hematuria

NCT03122964

Bladder Cancer Hematuria

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. Voided urine samples will be collected prior to cystoscopy. Cell free DNA and cellular DNA will both be extracted and analyzed. A blood sample will be taken. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. Next generation sequencing will be applied and hotspots mutations in DNA from urine, blood and tumor. Logistic regression was used to analyze the association between predictor variables and bladder cancer. The investigators will confirm a couple of common mutations occured in urine-DNA and blood-derived DNA simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. Moreover, external consistency test will be performed on subsequent patients collection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer Biomarker Diagnosis Urine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnosed Urinary Bladder Cancers

Patients who are being monitored for bladder cancer will be the experimental group to test the urine-DNA by next generation sequencing for bladder cancer biomarkers

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

The obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm.

Non-Urinary Bladder Cancers

Patients being treated for gross hematuria will provide a negative control to provide data from testing by next generation sequencing for biomarkers in patients being treated for other diseases.

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

The obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Next generation sequencing

The obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with gross hematuria or other clinical sympton suspected of bladder cancer.
* male or female patients aged \>= 18 years.
* available tumor tissue, urine and blood sample.
* signed informed consent form.

Exclusion Criteria

* prior diagnosis of cancer except bladder cancer
* age under 18 years
* individuals unwilling to sign the IRB-approved consent form
* comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No