Clinical trial NCT04948528: Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
Official title: Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Tract Urothelial Carcinoma
Keywords: upper tract urothelial carcinoma
urine
DNA methylation
somatic mutation
Lead sponsor: AnchorDx Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University First Hospital
name: Peking University Third Hospital
name: Peking Union Medical College Hospital
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Sir Run Run Shaw Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2021-07-02
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: suspected upper tract urothelial carcinoma patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of urine DNA methylation/somatic mutation test
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian HUANG, MD
role: STUDY_CHAIR
References: