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Trial Title:
UroCAD for Hematuria Evaluation--A Prospective, Multi-center Study
NCT ID:
NCT05893316
Condition:
Hematuria
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma, Transitional Cell
Hematuria
Conditions: Keywords:
non-invasive
urothelial carcinoma
hematuria evaluation
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
urine sample collection
Description:
The level of CIN The extracted DNA from urine exfoliated cells will be analyzed by UroCAD
to determine the level of CIN.
Arm group label:
Hematuria patients
Arm group label:
Non-hematuria patients
Summary:
Hematuria is recognized as an important sigh of potential urinary tract malignancy.
Therefore, understanding the disease processes and discovering the potential urothelial
carcinoma (UC) underlying this important sign is critical. Cystoscopy, urine cytology and
imaging are most reliable methods for UC diagnosis, but certain drawbacks exist for these
methods, such as invasiveness or inaccuracy. Chromosomal instability (CIN) is a hallmark
of human cancer, and it's related with tumor stage and grade. Previous research has
proved that analyzing CIN of the DNA extracted from urothelial cells in urine samples
seems a promising method for detecting UC. Here we intend to assess CIN's performance for
hematuria evaluation.
Detailed description:
Hematuria is defined as the presence of 3 or more red blood cells per high-power field
(RBC/HPF) under microscopic examination of the urine, which is an important sigh of
genitourinary system disease, especially UC. Several methods can be adopted for hematuria
evaluation. Cystoscopy is a key component of the hematuria evaluation because it is a
reliable way to evaluate the bladder and urethra. Biopsy can also be performed through
cystoscopy, making it the "gold standard" for bladder cancer diagnosis. Despite its high
reliability and accuracy, it's an invasive examination related with complications such as
injury to the urethra, infection, and discomfort. Flat lesions may also be omitted under
cystoscopy. Urine cytology is another important method for UC evaluation, but it has a
sensitivity of only 15.8%-54.5%.
CIN refers to the ongoing acquisition of genomic alterations, it can range from point
mutations to small-scale genomic alterations and gross chromosomal rearrangements.
60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN is
presented in UC and it has been adopted as a diagnostic method for UC, such as UroVysion
test. Previously, CIN detected by low-coverage whole genome sequencing proved to be a
reliable method for UC diagnosis and was named as Urine Exfoliated Cells Copy Number
Aberration Detector (UroCAD). In this prospective, multi-canter, observational clinical
trial, we intend to assess the possibility of UroCAD as an additional diagnostic tool for
hematuria patients by collecting and analyzing 30 ml of urine sample from hematuria
patient across 5 centers.
Criteria for eligibility:
Study pop:
Patients presented with hematuria (≥ 3 RBCs/HPF) and patients with malignancy other than
urothelial carcinoma in Changhai Hospital, Tongji Hospital, Renji Hospital, First
Affiliated Hospital of Xian Jiaotong University, and Gulou Hospital.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Participants aged ≥ 18 years and signed informed consent form.
- Participants presented with hematuria (≥ 3 RBCs/HPF) and meet one of the following
criteria:
1. Patients recommended to undergo cystoscopy or ureteroscopy;
2. Patients with treatment-naïve, pathology-confirmed urothelial carcinoma;
3. Patients diagnosed with benign genitourinary disease.
- Participants diagnosed with cancer other than urothelial carcinoma.
Exclusion Criteria:
- Participants with history of urothelial carcinoma.
- Participants with urothelial carcinoma accompanied by other malignancy.
- Individuals unwilling to sign the consent form or unwilling to provide urine sample
for test or quality of urine sample is poor.
- Patients unsuitable for this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
June 1, 2023
Completion date:
February 1, 2024
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05893316
