Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 5:17 AM
Study NCT ID:
NCT04102904
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2019-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prostate Liquid Study (PLiS)
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
A Multi-centre Validation Cohort Study Evaluating the Chemical Elements Content in Semen and Expressed Prostatic Secretions in the Diagnosis and Characterisation of Prostate Cancer, in Men Identified as Having a Risk of Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLiS
Brief Summary:
A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.
Detailed Description:
A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy.
The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.
In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.
In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: