Urine-DNA Biomarkers in Detecting Bladder Cancer

Central South University

Status: Completed

Conditions: Bladder Cancer; Urine; Diagnosis; Biomarker

Treatments: Diagnostic Test: Next generation sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT03066310

XYURO002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

125 participants in 2 patient groups

Diagnosed Urinary Bladder Cancers

Description:

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

Treatment:

Diagnostic Test: Next generation sequencing

Non-Urinary Bladder Cancers

Description:

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.

Treatment:

Diagnostic Test: Next generation sequencing