Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma

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Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Diagnostic Performance for the detection of urothelial carcinoma

Secondary Outcome

 Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma

Condition

Urothelial Carcinoma

Intervention

Active Comparator: Pathology

Study Arms / Comparison Groups

 Urothelial carcinoma group
Description:  Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1200

Start Date

August 1, 2019

Completion Date

August 31, 2020

Primary Completion Date

August 31, 2020

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jian HUANG, MD, +86-13430306339, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04314245

Organization ID

AnchorDx-BC004


Responsible Party

Sponsor

Study Sponsor

AnchorDx Medical Co., Ltd.

Collaborators

 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Sponsor

Jian HUANG, MD, Study Chair, Sun Yat-sen Memorial Hospital,Sun Yat-sen University


Verification Date

March 2020