Bladder Cancer, Urothelial Carcinoma
Conditions
Keywords
Bladder Cancer, Urine, DNA methylation, Somatic mutation
Brief summary
Clinical trial to evaluate the performance characteristics(sensitivity and specificity) of AnchorDx's urine DNA methylation/somatic mutation profiling assay for detecting urothelial carcinoma compared to pathology in patients.
Detailed description
This is a prospective study that involves 11 centers in China and 1200 participants. The assay analyzes the DNA methylation/somatic mutation profiles of bladder cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The performance characteristics(sensitivity and specificity) of the assay for detection of urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
Interventions
OTHERActive Comparator: Pathology
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Routine clinical diagnosis and treatment of benign disease of the urinary system
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
OTHERGenetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay
A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
West China Hospital
RenJi Hospital
Tongji Hospital
Peking University People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital with Nanjing Medical University
Southern Medical University, China
Nanfang Hospital, Southern Medical University
Sichuan Cancer Hospital and Research Institute
Affiliated Hospital & Clinical Medical College of Chengdu University
AnchorDx Medical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Urothelial carcinoma group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery. 2. interference group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery. 3. Control group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with urinary disease such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis. All enrollee are able to provide legally effective informed consent. 4. Healthy volunteers group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before physical examination.
Exclusion criteria
1. Urothelial carcinoma/Interference group/Control group * Has had diagnosed with other cancers. * Patients diagnosed with non-urological cancer. * Failed to provide a written informed consent. 2. Healthy volunteers group: * Volunteers with abnormal test results of urine analysis or urological ultrasound test. * Volunteers sceptical of cancers from non-urological origin in a normal results of urine analysis or urological ultrasound. * Failed to provide legally effective informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance for the detection of urothelial carcinoma | 1 Years | The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma | 1 Years | Sensitivity and specificity of urine DNA methylation/somatic mutation profiling assay in different pathological stages and histologic grades of urothelial carcinoma. |
Countries
China
Outcome results
None listed