The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

August 19, 2024 updated by: Wuhan Ammunition Life-tech Co., Ltd

The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma: a Single Center Prospective Study

The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All urothelial carcinoma patients were not Ta stage or low-grade who met the indications for surgery. Surgical modalities include transurethral resection of bladder tumours (TURbt), partial cystectomy, radical nephroureterectomy, and kidney-sparing surgery. Urine samples were collected before and after surgery, and IUrisure methylation test was performed on each urine sample. The follow-up period was 24 months, and the patients underwent routine tests during the follow-up period. The gold standard for recurrence of urothelial carcinoma is surgical/biopsy pathology.

Description

Inclusion Criteria:

  1. Patients with high suspicion/confirmed urothelial carcinoma by CT, CTU, MR and other imaging examinations and meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
  2. Patients with highly suspected/confirmed recurrence of urothelial carcinoma who meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
  3. The patient agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

  • (1) Patients with urothelial carcinoma combined with other malignant tumors; (2) Patients with a history of other non-urothelial carcinoma cancers; (3) Samples that are not urothelial carcinoma in surgical pathology; (4) Samples of Ta/low-grade urothelial carcinoma shown by surgical pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urothelial carcinoma Patients
Patients with urothelial carcinoma, which can be primary or recurrent, should be eligible for surgery including transurethral resection of bladder tumours (TURbt), partial cystectomy, radical nephroureterectomy, and kidney-sparing surgery. Urine samples were collected before and after surgery. The follow-up period was 24 months, and the patients underwent routine tests during the follow-up period. The gold standard for recurrence of urothelial carcinoma is surgical/biopsy pathology.
Diagnostic test: IUrisure test
Postoperative patients are followed up every three months on average, and IUrisure test was performed at each follow-up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of IUrisure test
Time Frame: Day 1
The proportion of negatives that are correctly identified as such by the gold standard
Day 1
Sensitivity of IUrisure test
Time Frame: Day 1
The proportion of positives that are correctly identified as such by the gold standard
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Ammunition Life-tech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDY003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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