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

AnchorDx Medical

Status: Enrolling

Conditions: Upper Tract Urothelial Carcinoma

Treatments: Other: Active Comparator: Clinical Diagnosis; Other: Active Comparator: Surgery Pathology or Cystoscopy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04948528

AnchorDx BC006

Details and patient eligibility

About

Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.

Full description

This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.

Enrollment: 490 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Case group:

• 1.Any male or female patient aged 18 or older.
• 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
• 3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
• 4.Able to provide legally effective informed consent.

Control group:

• 1.Any male or female patient aged 18 or older.
• 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
• 3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
• 4.Able to provide legally effective informed consent.

Exclusion criteria

• 1.Patients had been diagnosed with cancer history.
• 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.

Trial design

490 participants in 2 patient groups

Case group:

Description:

All suspected upper tract urothelial carcinoma participants will be assigned to case group.

Treatment:

Other: Active Comparator: Surgery Pathology or Cystoscopy

Control group

Description:

All suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group.

Treatment:

Other: Active Comparator: Clinical Diagnosis