Brief Title
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
Official Title
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
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.
Study Type
Observational
Primary Outcome
Diagnostic Performance for the detection of urothelial carcinoma
Secondary Outcome
Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma
Condition
Urothelial Carcinoma
Intervention
Active Comparator: Pathology
Study Arms / Comparison Groups
Urothelial carcinoma group
Description: Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1200
Start Date
August 1, 2019
Completion Date
August 31, 2020
Primary Completion Date
August 31, 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jian HUANG, MD, +86-13430306339, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04314245
Organization ID
AnchorDx-BC004
Responsible Party
Sponsor
Study Sponsor
AnchorDx Medical Co., Ltd.
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor
Jian HUANG, MD, Study Chair, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Verification Date
March 2020