Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
NCT ID: NCT04948528
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
490 participants
OBSERVATIONAL
2020-09-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
NCT04314245
Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma
NCT05595408
Development of a Non-Invasive DNA Methylation-Based Assay System for the Risk Assessment of Urothelial Carcinoma
NCT00867620
Identifying Methylation Biomarkers for Monitoring Bladder Tumors
NCT00244205
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
NCT05643690
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Case group:
All suspected upper tract urothelial carcinoma participants will be assigned to case group.
Active Comparator: Surgery Pathology or Cystoscopy
Case group will be followed up with 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.
Active Comparator: Clinical Diagnosis
Control group will be diagnosed in clinical.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active Comparator: Surgery Pathology or Cystoscopy
Case group will be followed up with surgery pathology or cystoscopy.
Active Comparator: Clinical Diagnosis
Control group will be diagnosed in clinical.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
Peking Union Medical College Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sir Run Run Shaw Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
AnchorDx Medical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jian HUANG, MD
Role: STUDY_CHAIR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AnchorDx BC006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.