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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05893316
Other study ID # CH-Hematuria-CIN
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date February 1, 2024

Study information

Verified date May 2023
Source Changhai Hospital
Contact Shuxiong Zeng, M.D., Ph.D.
Phone +8618930568759
Email zengshuxiong@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date February 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
urine sample collection
The level of CIN The extracted DNA from urine exfoliated cells will be analyzed by UroCAD to determine the level of CIN.

Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Changhai Hospital First Affiliated Hospital Xi'an Jiaotong University, RenJi Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

McDougal, W. Scott, et al. Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences, 2015.

Sansregret L, Vanhaesebroeck B, Swanton C. Determinants and clinical implications of chromosomal instability in cancer. Nat Rev Clin Oncol. 2018 Mar;15(3):139-150. doi: 10.1038/nrclinonc.2017.198. Epub 2018 Jan 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity Comparison of the sensitivity of the UroCAD analysis versus clinically-acceptable threshold, defined as 75%. through study completion, an average of 8 months
Primary specificity Comparison of the specificity of the UroCAD analysis versus clinically-acceptable threshold, defined as 95%. through study completion, an average of 8 months
Primary Sensitivity among hematuria patients Sensitivity of UroCAD in detecting urothelial carcinoma among hematuria patients through study completion, an average of 8 months
Primary Specificity among hematuria patients Specificity of UroCAD in detecting urothelial carcinoma among hematuria patients through study completion, an average of 8 months
Secondary Comparison of Sensitivity Comparison of the sensitivity of the UroCAD analysis versus urine cytology through study completion, an average of 8 months
Secondary Comparison of Specificity Comparison of the Specificity of the UroCAD analysis versus urine cytology through study completion, an average of 8 months
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