Upper Tract Urothelial CarcinomaNCT04948528
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
An observational study of Upper Tract Urothelial Carcinoma, run by AnchorDx Medical Co., Ltd. at 1 site in China.
Trial summary
Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- Active Comparator: Surgery Pathology or Cystoscopy and Active Comparator: Clinical Diagnosis
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: suspected upper tract urothelial carcinoma patients
Who may be able to join
- Case group:
- 1.Any male or female patient aged 18 or older.
- 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- 3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
- 4.Able to provide legally effective informed consent.
- Control group:
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- 1.Any male or female patient aged 18 or older.
- 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- 3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
- 4.Able to provide legally effective informed consent.
Who cannot join
- 1.Patients had been diagnosed with cancer history.
- 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, 510120
Xu CHEN, MD, +86-13430306339, chenx457@mail.sysu.edu.cn
Jian HUANG, MD
About this study
Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.
Read the detailed description
This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
- Conditions
- Upper Tract Urothelial Carcinoma
- Being tested
- Active Comparator: Surgery Pathology or Cystoscopy, Active Comparator: Clinical Diagnosis
- Keywords
- upper tract urothelial carcinoma, urine, DNA methylation, somatic mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Surgery Pathology or CystoscopyOther
Case group will be followed up with surgery pathology or cystoscopy.
Active Comparator: Clinical DiagnosisOther
Control group will be diagnosed in clinical.
| Study group | Role | What they receive |
|---|---|---|
| Case group: | All suspected upper tract urothelial carcinoma participants will be assigned to case group. Receives: Other: Active Comparator: Surgery Pathology or Cystoscopy | |
| Control group | All suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group. Receives: Other: Active Comparator: Clinical Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of urine DNA methylation/somatic mutation test
Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Sep 2020
- Primary completion25 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract 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
- 490 participants (estimated)
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, Peking University First Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhengzhou 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
- NCT04948528
- Sponsor's protocol ID
- AnchorDx BC006
- Status last verified
- May 2023
- First submitted
- 22 Jun 2021
- Last updated
- 24 May 2023
- Results posted
- 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 Upper Tract Urothelial Carcinoma Detection
- ClinicalTrials.gov ID
- NCT04948528
- Acronym / sponsor ID
- AnchorDx BC006
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- upper tract urothelial carcinoma, urine, DNA methylation, somatic mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- AnchorDx Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University First Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jul 2021 (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 determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.
Detailed description
This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group: | – | Other: Active Comparator: Surgery Pathology or CystoscopyAll suspected upper tract urothelial carcinoma participants will be assigned to case group. |
| Control group | – | Other: Active Comparator: Clinical DiagnosisAll suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- suspected upper tract urothelial carcinoma patients
Key inclusion criteria (10 listed)
- 1.Any male or female patient aged 18 or older.
- 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- 3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
- 4.Able to provide legally effective informed consent.
- 1.Any male or female patient aged 18 or older.
Key exclusion criteria (2 listed)
- 1.Patients had been diagnosed with cancer history.
- 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
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: Surgery Pathology or CystoscopyCase group will be followed up with surgery pathology or cystoscopy. | Other | Case group: |
| Active Comparator: Clinical DiagnosisControl group will be diagnosed in clinical. | Other | Control group |
Primary outcome
Efficacy of urine DNA methylation/somatic mutation test
Time frame: 1 Year
Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)
Results and safety
Results are not available in the source record.
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 Upper Tract Urothelial Carcinoma, 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 10 inclusion and 2 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Chen, MD (+86-13430306339, chenx457@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of urine DNA methylation/somatic mutation test (time frame: 1 Year). 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.