To Identify Potential New Urine Marker Panel for Cancer Screening

Recruiting

• Conditions: Cancer

• Registration Number: NCT04689802
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Polyamines are naturally produced metabolites in our cells. There were some reports suggested the urinary levels of polyamines were altered in patients with different cancers. This study is to explore the use of urinary polyamine for the diagnosis of common cancers.

Detailed Description

Urine tests is a simple, non-invasive approach for cancer detection. One example of such cancer biomarkers are natural polyamines. Recently, there are also other reports on the use of polyamines in diagnosis of other cancers. In this larger scale study, with inclusion of subjects with different cancer types, to further assess the correlation urine polyamines and other urine metabolite markers for the diagnosis of different cancer types and investigate their role as a potential non-invasive marker for cancer detection and monitoring.

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Study Start: 2021-01-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Adult patients with age > 18 years old.
2. For cancer patients, a histological diagnosis of cancer is available.
3. For normal control, there is no diagnosis of cancer in the medical record.

Exclusion Criteria

1. Patient with recent urinary tract infection within 6 weeks prior to urine collection.
2. Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc, within 6 weeks prior to urine collection.
3. Patient refused or unable to provide consent for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of cancer detection by urine polyamines	1 month after surgery	Urine samples will be prepared and analyzed by ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve for overall and individual cancer diagnosis will be performed.pathological result will be assessed.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong