Condition category
Cancer
Date applied
07/09/2012
Date assigned
10/10/2012
Last edited
27/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr David Bramwell

ORCID ID

Contact details

Chief Technical Officer
Biosignatures Limited
Keel House
Garth Heads
Newcastle-upon-Tyne
NE1 2JE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR-CT-001 2012/July (02)

Study information

Scientific title

BiopSave: a blinded, prospective, non-randomised observational controlled study to validate a novel proteomic blood test for the diagnosis of prostate cancer

Acronym

BiopSave

Study hypothesis

It is hypothesised that a panel of candidate biomarkers, identified during an earlier pilot study as being present in the blood of prostate cancer patients, can be measured using the Biosignatures proteomics platform and successfully used to predict the likelihood of a patient having prostate cancer diagnosed by prostate biopsy. Diagnostic predictions will be made blinded to biopsy result and the accuracy of these predictions compared to actual biopsy results at designated analysis milestones by an independent data monitoring committee. The null hypothesis is that the candidate biomarkers identified during the pilot study had a coincidental association with the patients known to have prostate cancer in that cohort and therefore have no ability to make diagnostic predictions regarding the likelihood of prostate cancer being detected by prostate biopsy in newly recruited patients.

Ethics approval

NRES Committee South Central - Oxford C, 19/07/2012, ref: 12/SC/0432

Study design

Blinded prospective non-randomised controlled observational study, with an anticipated duration of 54 months

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

www.biosignatures.com/BiopSave

Condition

Prostate cancer in-vitro diagnostic assay validation

Intervention

Aside from taking of blood samples on one occasion, the study is non-interventional.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A validation of the performance of the Biosignatures BiopSave product, demonstrating the capability of this proteomic blood test to predict the diagnostic results of prostate biopsies carried out on patients presenting for assessment at urology clinic with the suspicion of having an undiagnosed prostate cancer, particularly those patients in a specific sub-set: PSA concentration between 2.5 and 20 ng/ml, DRE findings not immediately suspicious of prostate cancer, have not undergone previous prostate biopsy or resection procedures.

Secondary outcome measures

1. A validation of the performance of the BiopSave product in patients who have a PSA concentration outside of the primary range of interest and/or who have DRE findings which are suspicious of prostate cancer and/or who have had prostate biopsy or resection procedures carried out in the past.
2. A comparison of the performance of the BiopSave product to a variety of other prostate disease biomarkers recently reported in the literature.
3. An assessment of the capability of the BiopSave product, or related refined versions of the assay to predict the overall prostate disease diagnostic status of study participants one year after initial prostate biopsy.

Overall trial start date

10/09/2012

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Are between 40 and 80 years of age
2. Are considered to possibly have an undiagnosed prostate cancer
3. Are considered suitable for prostate biopsy
4. Are able to provide written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

800

Participant exclusion criteria

1. Are known to currently have another cancer or have been treated for cancer within the last five years
2. Are not considered suitable for prostate biopsy
3. Are outside of the target age range
4. Are infected with HIV, a viral Hepatitis or another highly-infectious blood-borne disease
5. Are incapable of providing written informed consent agreeing to participation in the study

Recruitment start date

10/09/2012

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Freeman Hospital
Freeman Road
Newcastle-upon-Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Biosignatures Limited (UK)

Sponsor details

c/o Dr Ben Chaffey
Clinical Operations Manager
Keel House
Garth Heads
Newcastle-upon-Tyne
NE1 2JE
United Kingdom
+44 (0)191 645 3645
ben.chaffey@biosignatures.com

Sponsor type

Industry

Website

http://www.biosignatures.com

Funders

Funder type

Industry

Funder name

Biosignatures Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be published in specialist urology journals following un-blinding and pivotal data analysis.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/10/2016: The overall trial end date has been updated from 31/03/2017 to 01/07/2018 and the recruitment end date has been updated from 31/03/2016 to 01/12/2016. 16/03/2015: The following changes were made to the trial record: 1. The overall trial end date was changed from 12/09/2014 to 31/03/2017 2. The target number of participants was changed from 500 to 800 3. The study design was changed from 'Two-year blinded prospective non-randomised controlled observational study' to 'Blinded prospective non-randomised controlled observational study, with an anticipated duration of 54 months'