To Identify Potential New Urine Marker Panel for Cancer Screening

NCT04689802 | Recruiting

• 1 other identifier: CRE-2020.611
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of cancer detection by urine polyamines

  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.

  1 month after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (8)

• Zhang DZ, Lau KM, Chan ES, Wang G, Szeto CC, Wong K, Choy RK, Ng CF. Cell-free urinary microRNA-99a and microRNA-125b are diagnostic markers for the non-invasive screening of bladder cancer. PLoS One. 2014 Jul 11;9(7):e100793. doi: 10.1371/journal.pone.0100793. eCollection 2014.

  PMID: 25014919 BACKGROUND

• Cheng THT, Jiang P, Teoh JYC, Heung MMS, Tam JCW, Sun X, Lee WS, Ni M, Chan RCK, Ng CF, Chan KCA, Chiu RWK, Lo YMD. Noninvasive Detection of Bladder Cancer by Shallow-Depth Genome-Wide Bisulfite Sequencing of Urinary Cell-Free DNA for Methylation and Copy Number Profiling. Clin Chem. 2019 Jul;65(7):927-936. doi: 10.1373/clinchem.2018.301341. Epub 2019 Apr 15.

  PMID: 30988170 BACKGROUND

• Russell DH. Increased polyamine concentrations in the urine of human cancer patients. Nat New Biol. 1971 Sep 29;233(39):144-5. doi: 10.1038/newbio233144a0. No abstract available.

  PMID: 5286749 BACKGROUND

• Lee SH, Yang YJ, Kim KM, Chung BC. Altered urinary profiles of polyamines and endogenous steroids in patients with benign cervical disease and cervical cancer. Cancer Lett. 2003 Nov 25;201(2):121-31. doi: 10.1016/s0304-3835(03)00014-4.

  PMID: 14607325 BACKGROUND

• Loser C, Folsch UR, Paprotny C, Creutzfeldt W. Polyamines in colorectal cancer. Evaluation of polyamine concentrations in the colon tissue, serum, and urine of 50 patients with colorectal cancer. Cancer. 1990 Feb 15;65(4):958-66. doi: 10.1002/1097-0142(19900215)65:43.0.co;2-z.

  PMID: 2297664 BACKGROUND

• 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.

  PMID: 10845272 BACKGROUND

• 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.

  PMID: 27598335 BACKGROUND

• Deng L, Ismond K, Liu Z, Constable J, Wang H, Alatise OI, Weiser MR, Kingham TP, Chang D. Urinary Metabolomics to Identify a Unique Biomarker Panel for Detecting Colorectal Cancer: A Multicenter Study. Cancer Epidemiol Biomarkers Prev. 2019 Aug;28(8):1283-1291. doi: 10.1158/1055-9965.EPI-18-1291. Epub 2019 May 31.

  PMID: 31151939 BACKGROUND

Related Links

• Hong Kong Cancer Registry 2018.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chi Fai Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai Ng, MD

CONTACT

35052625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: January 20, 2021
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)