Clinical trial NCT04689802: To Identify Potential New Urine Marker Panel for Cancer Screening
Official title: To Identify Potential New Urine Marker Panel for Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 2000 patients who has diagnosis of various cancers, and another 500 patients with no history of cancer will be recruited for the study. The sample size is based on the projected number of patients that can be recruited during the proposed study period.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The sensitivity and specificity of cancer detection by urine polyamines
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Leveque J, Foucher F, Bansard JY, Havouis R, Grall JY, Moulinoux JP. Polyamine profiles in tumor, normal tissue of the homologous breast, blood, and urine of breast cancer sufferers. Breast Cancer Res Treat. 2000 Mar;60(2):99-105. doi: 10.1023/a:1006319818530.
citation: Tsoi TH, Chan CF, Chan WL, Chiu KF, Wong WT, Ng CF, Wong KL. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers. PLoS One. 2016 Sep 6;11(9):e0162217. doi: 10.1371/journal.pone.0162217. eCollection 2016.
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