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

Completed

• Conditions: Urothelial Carcinoma; Bladder Cancer

• Registration Number: NCT04314245
• Lead Sponsor: AnchorDx Medical Co., Ltd.

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 Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Primary Completion: 2021-11-30
• Study Completion: 2022-08-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1170

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance for the detection of urothelial carcinoma	1 Years	The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma	1 Years	Sensitivity and specificity of urine DNA methylation/somatic mutation profiling assay in different pathological stages and histologic grades of urothelial carcinoma.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University,; 🇨🇳 Guangzhou, Guangdong, China