Status:
COMPLETED
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
Lead Sponsor:
AnchorDx Medical Co., Ltd.
Collaborating Sponsors:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
West China Hospital
Conditions:
Urothelial Carcinoma
Bladder Cancer
Eligibility:
All Genders
18+ years
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...
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-invasive...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
1170 Patients enrolled
Trial Details
Trial ID
NCT04314245
Start Date
August 1 2019
End Date
August 31 2022
Last Update
May 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, China, 510120