Upper Tract Urothelial Carcinoma
Conditions
Keywords
upper tract urothelial carcinoma, urine, DNA methylation, somatic mutation
Brief 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.
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.
Interventions
OTHERActive Comparator: Surgery Pathology or Cystoscopy
Case group will be followed up with surgery pathology or cystoscopy.
Control group will be diagnosed in clinical.
Sponsors
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
AnchorDx Medical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: * 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
* 1.Patients had been diagnosed with cancer history. * 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of urine DNA methylation/somatic mutation test | 1 Year | Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology) |
Countries
China
Contacts
Primary ContactXu Chen, MD
Backup ContactXia Li
Outcome results
None listed