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

May 23, 2023 updated by: AnchorDx Medical Co., Ltd.
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

1170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects consisted of four types : 1) Patients with urothelial carcinoma; 2) Patients with the other bladder cancer (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer); 3) Patients with benign disease of the urinary system, such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis; 4) Healthy volunteers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urothelial carcinoma group
Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
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.
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
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.
A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.
Routine clinical diagnosis and treatment of benign disease of the urinary system
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.
A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance for the detection of urothelial carcinoma
Time Frame: 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.
1 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma
Time Frame: 1 Years
Sensitivity and specificity of urine DNA methylation/somatic mutation profiling assay in different pathological stages and histologic grades of urothelial carcinoma.
1 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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