Clinical trial NCT03066310: Urine-DNA Biomarkers in Detecting Bladder Cancer
Official title: Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Biomarker
Diagnosis
Urine
Keywords: Bladder cancer
Urine
DNA biomarker
Diagnosis
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Central South University
name: The Third Xiangya Hospital of Central South University
name: Hunan Cancer Hospital
name: Hunan Provincial People's Hospital
name: Second People's Hospital of Hunan
First posted: 2017-02-28
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients diagnosed with suspected bladder cancer in Xiangya Hospital of Central South University from February of 2017 till the end of this study.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: sensitivity of urinalysis by Urine-DNA test
timeFrame: through study completion, an average of 8 months
measure: specificity of urinalysis by Urine-DNA test
timeFrame: through study completion, an average of 8 months
measure: Identification of positive urine-DNA test results with the next generation sequencing
timeFrame: through study completion, an average of 8 months
measure: Identification of urine-DNA mutations with the next generation sequencing to create an diagnosis algorithm.
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: sensitivity of blood DNA test
timeFrame: through study completion, an average of 8 months
measure: specificity of blood DNA test
timeFrame: through study completion, an average of 8 months
measure: comparison of the sensitivity of the urine DNA versus blood DNA test
timeFrame: through study completion, an average of 8 months
measure: comparison of the specificity of the urine DNA versus blood DNA test
timeFrame: through study completion, an average of 8 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South Univeristy
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South Univeristy
name: Long Wang, M.D., Ph.D
role: STUDY_CHAIR
References: