CancerNCT04689802
To Identify Potential New Urine Marker Panel for Cancer Screening
An observational study of Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,500 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jan 2021to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 3953, ngcf@surgery.cuhk.edu.hk
About this study
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.
Read the 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start20 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689802
- Sponsor's protocol ID
- CRE-2020.611
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25014919Cheng 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.
PubMed 30988170Russell 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.
PubMed 5286749Lee 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.
PubMed 14607325Loser 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.
PubMed 2297664Leveque 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.
PubMed 10845272Tsoi 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.
PubMed 27598335Deng 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.
PubMed 31151939
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify Potential New Urine Marker Panel for Cancer Screening
- ClinicalTrials.gov ID
- NCT04689802
- Acronym / sponsor ID
- CRE-2020.611
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 25014919Zhang 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.
- Background: PubMed 30988170Cheng 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.
- Background: PubMed 5286749Russell 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.
- Background: PubMed 14607325Lee 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.
- Background: PubMed 2297664Loser 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.
- Background: PubMed 10845272Leveque 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.
- Background: PubMed 27598335Tsoi 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.
- Background: PubMed 31151939Deng 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.
- Hong Kong Cancer Registry 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Fai Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Fai Ng, MD (35052625, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of cancer detection by urine polyamines (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689802, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.