NCT04948528

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

June 22, 2021

Last Update Submit

May 23, 2023

Conditions

Upper Tract Urothelial Carcinoma

Keywords

upper tract urothelial carcinomaurineDNA methylationsomatic mutation

Outcome Measures

Primary Outcomes (1)

  • Efficacy of urine DNA methylation/somatic mutation test

    Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)

    1 Year

Study Arms (2)

Case group:

All suspected upper tract urothelial carcinoma participants will be assigned to case group.

Other: Active Comparator: Surgery Pathology or Cystoscopy

Control group

All suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group.

Other: Active Comparator: Clinical Diagnosis

Interventions

Active Comparator: Surgery Pathology or CystoscopyOTHER

Case group will be followed up with surgery pathology or cystoscopy.

Case group:
Active Comparator: Clinical DiagnosisOTHER

Control group will be diagnosed in clinical.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

suspected upper tract urothelial carcinoma patients

You may qualify if:

  • Case 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 upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
  • Able to provide legally effective informed consent.
  • 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 ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
  • Able to provide legally effective informed consent.

You may not qualify if:

  • Patients had been diagnosed with cancer history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

First void and non-first-void urine

MeSH Terms

Interventions

Cystoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Jian HUANG, MD

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

    STUDY CHAIR

Central Study Contacts

Xu Chen, MD

CONTACT

+86-13430306339chenx457@mail.sysu.edu.cn

Xia Li

CONTACT

+86-15902059556xia_li@anchordx.com

Study Design

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

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 2, 2021

Study Start

September 1, 2020

Primary Completion

June 25, 2023

Study Completion

December 31, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)