NCT04314245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,170

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

March 17, 2020

Last Update Submit

May 23, 2023

Conditions

Urothelial CarcinomaBladder Cancer

Keywords

Bladder CancerUrineDNA methylationSomatic mutation

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Performance for the detection of urothelial carcinoma

    The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy.

    1 Years

Secondary Outcomes (1)

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

    1 Years

Study Arms (4)

Urothelial carcinoma group

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

Other: Active Comparator: PathologyOther: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

interference group

Subjects who 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 surgical pathology.

Other: Active Comparator: PathologyOther: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

Control group

Subjects who clinically diagnosed with benign disease of the urinary system, such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis.

Other: Active Comparator: Clinical DiagnosisOther: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

Healthy volunteers group

Volunteers who have a normal routine urine test / ultrasound examination of the urinary system and do not carry suspected tumors of other organs.

Other: Active Comparator: Clinical diagnosisOther: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay

Interventions

Active Comparator: PathologyOTHER

Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.

Urothelial carcinoma groupinterference group
Active Comparator: Clinical diagnosisOTHER

Routine clinical diagnosis and treatment of benign disease of the urinary system

Control group
Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assayOTHER

A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.

Control groupHealthy volunteers groupUrothelial carcinoma groupinterference group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine Specimens

MeSH Terms

Conditions

Carcinoma, Transitional CellUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jian HUANG, MD

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

August 1, 2019

Primary Completion

November 30, 2021

Study Completion

August 31, 2022

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)