NCT04339920|Withdrawn
Study Stopped
No funding
Spermine Measuring Device Evaluation Protocol
To Evaluate the Performance of a Urine Spermine Measuring Device in Predicting Prostate Biopsy Result
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Sponsor study identifier
observational
0
1 country
1
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prostate gland is a clinically important male sexual organ and its main function is for the production of semen. Globally, it is the second most common cancer in men globally and is also the fifth cancer cause for death in male. Despite the improvement in the understanding of prostate cancer, the current usage of serum prostate specific antigen (PSA) as a diagnostic marker is still not ideal. Many patients with elevated PSA and then subjected to prostate biopsy were found to have no prostate cancer. Therefore, there is a need to discover new biological markers to improve the current situation in diagnosis and also management of prostate cancer. In our recent studies, urinary spermine levels have been shown to correlate well with prostate cancer diagnosis and cancer aggressiveness. Due to its nature, it could provide a more convenient and non-invasive method for detecting prostate cancer. In order to further improve the accessibility of the test, a simple urine measuring device has been designed to allow more simple and practical usage of the test in clinical setting.The purpose of this study was to evaluate the accuracy of this newly designed urine measuring device for urinary spermine in predicting your prostatic biopsy result.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
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April 2, 2020
Actual (reported)April 9, 2020
Actual (reported)September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Correlation of the Spermine measuring device and final prostate biopsy results.
By comparing the urine spermine level results of the spermine measuring device with the prostate biopsy pathology
At baseline
Accuracy of the Spermine measuring device in measuring the urine spermine level
At baseline
Chinese patients with clinical suspicious of prostate cancer, due to elevated serum PSA or abnormal digital rectal examination, will be recruited for the study from the Prince of Wales Hospital and North District Hospital.
The Spermine Measuring Device (SMD) is a simple device, with automatic urine aspiration and also spermine level assessment. First about 30 cc urine will be freshly collected by a prepared collection device. Then the cap of the SMD will be removed and the aspiration tip of the device will be immersed into the urine specimen. After firmly pressed on the device, a small sample of urine will be aspirated into the SMD. The device will then automatically assess the urine spermine level. The result will then be read at a indicator window after about 5 minutes. If the level was below a pre-set cutoff, i.e. suggestive of having increase risk of prostate cancer, the indicator window will turn into red colour. However, if the spermine level is higher than the cutoff value, i.e. low risk of having cancer, the indicator window will turn blue.
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Chinese patients with clinical suspicious of prostate cancer, due to elevated serum PSA or abnormal digital rectal examination, will be recruited for the study from the Prince of Wales Hospital and North District Hospital.
Prince of Wales Hospital
Shatin, Hong Kong
Hong Kong Cancer registry 2017.
Wong HF, Yee CH, Teoh JY, Chan SY, Chiu PK, Cheung HY, Hou SS, Ng CF. Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades. Asian J Androl. 2019 Jan 1;21(1):104-106. doi: 10.4103/aja.aja_75_18. No abstract available.
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.
Serum PSA level will be collected. Up to 100cc of urine will be freshly collected from patient before they undergo prostate biopsy.
Chi Fai NG, MD
Chinese University of Hong Kong
0 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2020
First Posted
April 9, 2020
Study Start
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Chiu PKF, Tsoi TH, Wong YP, Teoh JYC, Lo KL, Ng CF, Wong KL. The novel urine Spermine test predicts prostate cancer: the first prospective evaluation. (Accepted poster presentation in EAU 2020)
Primary Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 4, 2022
Record last verified: 2021-12
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