Urothelial CarcinomaNCT04314245
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
An observational study of Urothelial Carcinoma and Bladder Cancer, run by AnchorDx Medical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urothelial Carcinoma, Bladder Cancer
- What is being tested?
- Active Comparator: Pathology, Active Comparator: Clinical Diagnosis and Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay
- How many people
- 1,170 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, 510120
About this study
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.
Read the 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.
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Being tested
- Active Comparator: Pathology, Active Comparator: Clinical Diagnosis, Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay
- Keywords
- Bladder Cancer, Urine, DNA methylation, Somatic mutation
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: PathologyOther
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Active Comparator: Clinical DiagnosisOther
Routine clinical diagnosis and treatment of benign disease of the urinary system
Active Comparator: Clinical diagnosisOther
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assayOther
A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.
| Study group | Role | What they receive |
|---|---|---|
| Urothelial carcinoma group | Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology. Receives: Other: Active Comparator: Pathology; Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay | |
| 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. Receives: Other: Active Comparator: Pathology; Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay | |
| 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. Receives: Other: Active Comparator: Clinical Diagnosis; Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay | |
| 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. Receives: Other: Active Comparator: Clinical diagnosis; Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Years
Secondary outcomes (1)
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.
Measured: 1 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Aug 2019
- Primary completion30 Nov 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnchorDx Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, West China Hospital, RenJi Hospital, Tongji Hospital, Peking University People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital with Nanjing Medical University, Southern Medical University, China, Nanfang Hospital, Southern Medical University, Sichuan Cancer Hospital and Research Institute, Affiliated Hospital & Clinical Medical College of Chengdu University
- Responsible party
- Sponsor
- Investigators
- Jian HUANG, MD, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314245
- Sponsor's protocol ID
- AnchorDx-BC004
- Status last verified
- May 2023
- First submitted
- 17 Mar 2020
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04314245
- Acronym / sponsor ID
- AnchorDx-BC004
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Keywords
- Bladder Cancer, Urine, DNA methylation, Somatic mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,170 participants (actual)
- Lead sponsor
- AnchorDx Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, West China Hospital, RenJi Hospital, Tongji Hospital, Peking University People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital with Nanjing Medical University, Southern Medical University, China, Nanfang Hospital, Southern Medical University, Sichuan Cancer Hospital and Research Institute, Affiliated Hospital & Clinical Medical College of Chengdu University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Urothelial carcinoma group | – | Other: Active Comparator: Pathology, Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assaySubjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology. |
| interference group | – | Other: Active Comparator: Pathology, Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assaySubjects 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. |
| Control group | – | Other: Active Comparator: Clinical Diagnosis, Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assaySubjects 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. |
| Healthy volunteers group | – | Other: Active Comparator: Clinical diagnosis, Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assayVolunteers who have a normal routine urine test / ultrasound examination of the urinary system and do not carry suspected tumors of other organs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Urothelial carcinoma group:
- interference group:
- Control group:
- Healthy volunteers group:
Key exclusion criteria (8 listed)
- Urothelial carcinoma/Interference group/Control group
- Healthy volunteers group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: PathologyRoutine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma. | Other | Urothelial carcinoma group, interference group |
| Active Comparator: Clinical DiagnosisRoutine clinical diagnosis and treatment of benign disease of the urinary system | Other | Control group |
| Active Comparator: Clinical diagnosisRoutine urine test and imaging diagnostic techniques, such as B-ultrasound. | Other | Healthy volunteers group |
| Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assayA urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis. | Other | Control group, Healthy volunteers group, Urothelial carcinoma group, interference group |
Primary outcome
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 secondary outcome
Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma
Time frame: 1 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian HUANG, MD study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Bladder Cancer, run by AnchorDx Medical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance for the detection of urothelial carcinoma (time frame: 1 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.