To Identify Potential New Urine Marker Panel for Cancer Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- The sensitivity and specificity of cancer detection by urine polyamines
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with age > 18 years old.
- •For cancer patients, a histological diagnosis of cancer is available.
- •For normal control, there is no diagnosis of cancer in the medical record.
Exclusion Criteria
- •Patient with recent urinary tract infection within 6 weeks prior to urine collection.
- •Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc, within 6 weeks prior to urine collection.
- •Patient refused or unable to provide consent for the study
Outcomes
Primary Outcomes
The sensitivity and specificity of cancer detection by urine polyamines
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
NG Chi Fai
Professor
Chinese University of Hong Kong