BiopSave: validation of a novel blood test for the diagnosis of prostate cancer
| ISRCTN | ISRCTN52361806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52361806 |
| Secondary identifying numbers | PR-CT-001 2012/July (02) |
- Submission date
- 07/09/2012
- Registration date
- 10/10/2012
- Last edited
- 07/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Mr David Miller
Scientific
Scientific
Biosignatures Limited
The Biosphere
Draymans Way
Newcastle Helix
Newcastle-upon-Tyne
NE4 5BX
United Kingdom
| Phone | +44 (0)191 6453645 |
|---|---|
| dave.miller@biosignatures.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN52361806_PIS_V2.pdf |
| Scientific title | BiopSave: a blinded, prospective, non-randomised observational controlled study to validate a novel proteomic blood test for the diagnosis of prostate cancer |
| Study 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(s) | NRES Committee South Central - Oxford C, 19/07/2012, ref: 12/SC/0432 |
| 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 |
| Primary outcome measure | 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 study start date | 10/09/2012 |
| Overall study end date | 01/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 800 |
| Total final enrolment | 624 |
| 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 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 | 30/06/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Freeman Hospital
Freeman Road
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Sponsor information
Biosignatures Limited (UK)
Industry
Industry
c/o Sarah Greenhalgh
Biosignatures Ltd
The Biosphere
Draymans Way
Newcastle Helix
Newcastle-upon-Tyne
NE4 5BX
United Kingdom
| Phone | +44 (0)191 645 3645 |
|---|---|
| info@biosignatures.com | |
| Website | http://www.biosignatures.com |
"ROR" |
https://ror.org/05jhd9y87 |
Funders
Funder type
Industry
Biosignatures Limited (UK)
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published in specialist urology journals following un-blinding and pivotal data analysis. Added 04/05/2021: Early Interim 1 results presented as a poster at the HUPO 2017 conference: Dracup et al (2017). "Bridging the "translation gap": A prospective study to validate biomarker panels predictive of prostate cancer." https://www.hupo.org/resources/Documents/Congress/2017/HUPO2017%20Abstracts-FINAL.pdf |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from David Miller. Added 04/05/2021: The datasets generated during and/or analyzed during the current study are/will be available upon request from Biosignatures Ltd. What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification. What other documents will be available? Study protocol, informed consent form, clinical study report. When will data be available (start and end dates)? Immediately following publication. No end date. With whom? Investigators whose proposed use of the data has been approved by and independent review committee (IRB/Ethics Committee). For what types of analyses? To achieve the aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to the Newcastle Biobank (https://www.ncl.ac.uk/biobanks/researchers/sample-access/) Whether participant consent was obtained? Participants gave consent for the use of their blood samples and deidentified data to be used for future research, as a “gift to science”. Comments on data anonymization. Identifiable data was not accessed outside of the care team. At recruitment participants were assigned a unique alpha-numeric identification code by research nursing staff. All information and blood samples which left the clinical site were only identifiable by this unique code. Any ethical or legal restrictions? None. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2 | 05/05/2021 | No | Yes | |
| Basic results | 04/05/2021 | 07/05/2021 | No | No |
Additional files
- ISRCTN52361806_PIS_V2.pdf
- Uploaded 05/05/2021
- ISRCTN52361806_BasicResults_04May21.pdf
- Uploaded 07/05/2021
Editorial Notes
07/05/2021: The basic results of this trial have been uploaded as an additional file.
05/05/2021: The contact and sponsor details were updated. The participant information sheet has been uploaded.
04/05/2021: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The intention to publish date was changed from 31/12/2018 to 31/12/2021.
3. The publication and dissemination plan and IPD sharing statement were updated.
20/03/2020: Internal review.
09/03/2017: The recruitment end date was changed from 01/12/2016 to 30/06/2017.
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'
