Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
NCT ID: NCT04314245
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1170 participants
OBSERVATIONAL
2019-08-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Urothelial carcinoma group
Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.
Active Comparator: Pathology
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Genetic 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.
interference group
Subjects who 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 surgical pathology.
Active Comparator: Pathology
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Genetic 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.
Control group
Subjects who clinically diagnosed with benign disease of the urinary system, such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis.
Active Comparator: Clinical Diagnosis
Routine clinical diagnosis and treatment of benign disease of the urinary system
Genetic 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.
Healthy volunteers group
Volunteers who have a normal routine urine test / ultrasound examination of the urinary system and do not carry suspected tumors of other organs.
Active Comparator: Clinical diagnosis
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
Genetic 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.
Interventions
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Active Comparator: Pathology
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Active Comparator: Clinical Diagnosis
Routine clinical diagnosis and treatment of benign disease of the urinary system
Active Comparator: Clinical diagnosis
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
Genetic 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
West China Hospital
OTHER
RenJi Hospital
OTHER
Tongji Hospital
OTHER
Peking University People's Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Southern Medical University, China
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Affiliated Hospital & Clinical Medical College of Chengdu University
UNKNOWN
AnchorDx Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jian HUANG, MD
Role: STUDY_CHAIR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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AnchorDx-BC004
Identifier Type: -
Identifier Source: org_study_id
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