Urine-DNA Biomarkers in Detecting Bladder Cancer

NCT03066310 | Completed DMC

• 1 other identifier: XYURO002
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Biomarker; Diagnosis; Urine

Keywords

Bladder cancer; Urine; DNA biomarker; Diagnosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• sensitivity of blood DNA test

  through study completion, an average of 8 months

• specificity of blood DNA test

  through study completion, an average of 8 months

• comparison of the sensitivity of the urine DNA versus blood DNA test

  through study completion, an average of 8 months

• comparison of the specificity of the urine DNA versus blood DNA test

  through study completion, an average of 8 months

Study Arms (2)

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

Diagnostic Test: Next generation sequencing

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.

Diagnostic Test: Next generation sequencing

Interventions

Next generation sequencing DIAGNOSTIC_TEST

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

Diagnosed Urinary Bladder Cancers; Non-Urinary Bladder Cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Central South University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Hunan Cancer Hospital: collaborator
• Hunan Provincial People's Hospital: collaborator
• Second People's Hospital of Hunan: collaborator

Study Sites (1)

Xiangya Hospital of Central South Univeristy

Changsha, Hunan, 410008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Voided urine samples were collected prior to the cystoscopy and stored at 4 ℃，within 12 hours after collection ,urine samples were processed in paticipant laboratories. Blood samples was collected. Tissue samples was collected( optional).

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Long Wang, M.D., Ph.D

  Xiangya Hospital of Central South Univeristy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 28, 2017
• Study Start: January 17, 2017
• Primary Completion: January 5, 2020
• Study Completion: January 10, 2020
• Last Updated: November 10, 2022

Record last verified: 2020-01

Locations

CN (1)