Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma

AnchorDx Medical

Status: Completed

Conditions: Bladder Cancer; Urothelial Carcinoma

Treatments: Other: Active Comparator: Pathology; Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay; Other: Active Comparator: Clinical Diagnosis; Other: Active Comparator: Clinical diagnosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04314245

AnchorDx-BC004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,170 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,170 participants in 4 patient groups

Urothelial carcinoma group

Description:

Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.

Treatment:

Other: Active Comparator: Pathology

Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

interference group

Description:

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.

Treatment:

Other: Active Comparator: Pathology

Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

Control group

Description:

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.

Treatment:

Other: Active Comparator: Clinical Diagnosis

Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

Healthy volunteers group

Description:

Volunteers who have a normal routine urine test / ultrasound examination of the urinary system and do not carry suspected tumors of other organs.

Treatment:

Other: Active Comparator: Clinical diagnosis

Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay