NCT03066310

Urine-DNA Biomarkers in Detecting Bladder Cancer

Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Bladder Cancer
• Biomarker
• Diagnosis
• Urine

Interventions

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

Timeline

• Start date: 2017-01-17
• Primary completion: 2020-01-05
• Completion: 2020-01-10
• First posted: 2017-02-28
• Last updated: 2022-11-10

Locations

1 site across 1 country: China