The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

NCT06564363 | Unknown

• 1 other identifier: BDY003
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urothelial Carcinoma

Keywords

Bladder cancer; Upper tract urothelial carcinomas; Recurrence; Methylation

Outcome Measures

Primary Outcomes (2)

• Specificity of IUrisure test

  The proportion of negatives that are correctly identified as such by the gold standard

  Day 1

• Sensitivity of IUrisure test

  The proportion of positives that are correctly identified as such by the gold standard

  Day 1

Study Arms (1)

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

Interventions

IUrisure test DIAGNOSTIC_TEST

Postoperative patients are followed up every three months on average, and IUrisure test was performed at each follow-up visit.

Urothelial carcinoma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• 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;
• The patient agrees to participate in this study and has signed the informed consent form.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wuhan Ammunition Life-tech Co., Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuesong Li

CONTACT

15801399116; pineneedle@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: June 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2023-11

Locations

CN (1)