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Trial Title:
The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma
NCT ID:
NCT06564363
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Conditions: Keywords:
Bladder cancer
Upper tract urothelial carcinomas
Recurrence
Methylation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
IUrisure test
Description:
Postoperative patients are followed up every three months on average, and IUrisure test
was performed at each follow-up visit.
Arm group label:
Urothelial carcinoma Patients
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Start date:
June 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Wuhan Ammunition Life-tech Co., Ltd
Agency class:
Industry
Source:
Wuhan Ammunition Life-tech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06564363
