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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314245
• Other study ID #: AnchorDx-BC004
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2023
• Source: AnchorDx Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1170
• Est. completion date: August 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University,	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor

Collaborator

AnchorDx Medical Co., Ltd.

Affiliated Hospital & Clinical Medical College of Chengdu University, First Affiliated Hospital Xi'an Jiaotong University, Nanfang Hospital of Southern Medical University, Peking University People's Hospital, RenJi Hospital, Sichuan Cancer Hospital and Research Institute, Southern Medical University, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Performance for the detection of urothelial carcinoma	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.	1 Years
Secondary	Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma	Sensitivity and specificity of urine DNA methylation/somatic mutation profiling assay in different pathological stages and histologic grades of urothelial carcinoma.	1 Years