- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04314245
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
Status
Completed
Conditions
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
- Name: Xu CHEN, MD
- Phone Number: +86-13430306339
- Email: chenxu-joshua@qq.com
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
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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:
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.
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.
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.
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:
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.
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.
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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.
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1 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Jian HUANG, MD, Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
Other Study ID Numbers
- AnchorDx-BC004
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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