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Recruiting

NCT Number: NCT04689802

To Identify Potential New Urine Marker Panel for Cancer Screening

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Location status: Recruiting

Location contact

Chi Fai NG, MD

CONTACT

[email protected]

3505 3953

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Fai Ng, MD

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 30, 2020
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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