UroCAD for Hematuria Evaluation--A Prospective, Multi-center Study

NCT05893316 | Unknown

• 1 other identifier: CH-Hematuria-CIN
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematuria; Urothelial Carcinoma

Keywords

non-invasive; urothelial carcinoma; hematuria evaluation

Outcome Measures

Primary Outcomes (4)

• sensitivity

  Comparison of the sensitivity of the UroCAD analysis versus clinically-acceptable threshold, defined as 75%.

  through study completion, an average of 8 months

• specificity

  Comparison of the specificity of the UroCAD analysis versus clinically-acceptable threshold, defined as 95%.

  through study completion, an average of 8 months

• Sensitivity among hematuria patients

  Sensitivity of UroCAD in detecting urothelial carcinoma among hematuria patients

  through study completion, an average of 8 months

• Specificity among hematuria patients

  Specificity of UroCAD in detecting urothelial carcinoma among hematuria patients

  through study completion, an average of 8 months

Secondary Outcomes (2)

• Comparison of Sensitivity

  through study completion, an average of 8 months

• Comparison of Specificity

  through study completion, an average of 8 months

Study Arms (2)

Hematuria patients

Hematuria patients (≥ 3 RBCs/HPF) with treatment-naïve, pathology-confirmed urothelial carcinoma or benign genitourinary system disease or with undetermined lesion presented with hematuria.

Diagnostic Test: urine sample collection

Non-hematuria patients

Patients without hematuria and diagnosed with pathology-confirmed cancer other than urothelial cancer.

Diagnostic Test: urine sample collection

Interventions

urine sample collection DIAGNOSTIC_TEST

The level of CIN The extracted DNA from urine exfoliated cells will be analyzed by UroCAD to determine the level of CIN.

Hematuria patients; Non-hematuria patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participants aged ≥ 18 years and signed informed consent form.
• Participants presented with hematuria (≥ 3 RBCs/HPF) and meet one of the following criteria:
• Patients recommended to undergo cystoscopy or ureteroscopy;
• Patients with treatment-naïve, pathology-confirmed urothelial carcinoma;
• Patients diagnosed with benign genitourinary disease.
• Participants diagnosed with cancer other than urothelial carcinoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Tongji Hospital: collaborator
• RenJi Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (2)

• 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.

  PMID: 29297505 BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples were collected form each patient and DNA was extracted form urine exfoliated cells for sequencing.

MeSH Terms

Conditions

Hematuria; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Shuxiong Zeng, M.D., Ph.D.

CONTACT

+8618930568759; zengshuxiong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. D.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)