Clinical trial NCT04314245: Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
Official title: Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Bladder Cancer
Keywords: Bladder Cancer
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: West China Hospital
name: RenJi Hospital
name: Tongji Hospital
name: Peking University People's Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: The First Affiliated Hospital with Nanjing Medical University
name: Southern Medical University, China
name: Nanfang Hospital, Southern Medical University
name: Sichuan Cancer Hospital and Research Institute
name: Affiliated Hospital & Clinical Medical College of Chengdu University
First posted: 2020-03-19
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. interference 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 bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery.
3. 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.
4. 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.

exclusion criteria:

1. 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.
2. 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.

Primary outcomes:
measure: Diagnostic Performance for the detection of urothelial carcinoma
timeFrame: 1 Years
Secondary outcomes:
measure: Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma
timeFrame: 1 Years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian HUANG, MD
role: STUDY_CHAIR
References: