Urine-DNA Biomarkers in Detecting Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066310
• Other study ID #: XYURO002
• Status: Completed
• Start date: January 17, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 10, 2020
• Est. primary completion date: January 5, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Bladder Cancer
• Diagnosis
• Disease
• Urinary Bladder Neoplasms
• Urine

Intervention

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.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South Univeristy	Changsha	Hunan

Sponsors (6)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Central South University, Hunan Cancer Hospital, Hunan Provincial People's Hospital, Second People's Hospital of Hunan, The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of urinalysis by Urine-DNA test	number of patients "declared positive" with the Urine-DNA test among the patients actually suffering from bladder carcinoma	through study completion, an average of 8 months
Primary	specificity of urinalysis by Urine-DNA test	number of patients "declared negative" with the Urine-DNA test among the patients without bladder carcinoma	through study completion, an average of 8 months
Primary	Identification of positive urine-DNA test results with the next generation sequencing	Identification of presence of positive urine-DNA test results with the designed panel.	through study completion, an average of 8 months
Primary	Identification of urine-DNA mutations with the next generation sequencing to create an diagnosis algorithm.	Identification of presence or absence of the mutations in urine-DNA with the next generation sequencing to create an idiagnosis algorithm	through study completion, an average of 8 months
Secondary	sensitivity of blood DNA test	number of patients "declared positive" with the blood-DNA test among the patients actually suffering from bladder carcinoma	through study completion, an average of 8 months
Secondary	specificity of blood DNA test	number of patients "declared negative" with the blood DNA test among the patients without bladder carcinoma	through study completion, an average of 8 months
Secondary	comparison of the sensitivity of the urine DNA versus blood DNA test	number of patients "declared positive" with the urine DNA test versus patients "declared positive" with the blood DNA test.	through study completion, an average of 8 months
Secondary	comparison of the specificity of the urine DNA versus blood DNA test	number of patients "declared negative" with the urine DNA test versus patients "declared negative" with the blood DNA test.	through study completion, an average of 8 months