To Identify Potential New Urine Marker Panel for Cancer Screening

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04689802

Enrollment

2500

Registered

2020-12-30

Start date

2021-01-20

Completion date

2026-03-31

Last updated

2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Hong Kong

Contacts

Primary ContactChi Fai Ng, MD

ngcf@surgery.cuhk.edu.hk35052625

Outcome results