Breast cancer biomarkers and treatment targets
| ISRCTN | ISRCTN40576403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40576403 |
| Protocol serial number | RHMCAN0738 (Protocol version 1.3 ) |
| Sponsor | University Hospital Southampton (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 09/05/2011
- Registration date
- 21/09/2011
- Last edited
- 03/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is now the most common cancer in the United Kingdom. More than 45,500 women per year are now diagnosed with breast cancer and this continues to increase. However, new targeted treatments such as herceptin have led to successful therapies. This project aims to study and investigate new targets for treating breast cancer.
Who can participate?
Patients with breast cancer
What does the study involve?
This study observes and investigates extra samples of breast cancer tissue that is not required for diagnosing the patient, or tissue that already exists in a tumour bank. Patients will have received normal clinical care.
What are the possible benefits and risks of participating?
Benefits of the study are that new treatments may be developed for breast cancer. There are no known risks associated with this study as patients are not directly involved.
Where is the study run from?
Southampton General Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2010 to October 2025
Who is funding the study?
Cancer Research UK
Who is the main contact?
Mr Ramsey Cutress
r.i.cutress@soton.ac.uk
Contact information
Scientific
CRUK Centre
Somers Building
Mailpoint 824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8079 5170 / 6184 |
|---|---|
| r.i.cutress@soton.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Open-label non-randomised retrospective study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Breast cancer biomarkers translational research and validation study |
| Study objectives | The aim of this study is to identify, futher understand, validate and characterise breast cancer molecules and biomarkers with a view to designing novel molecular rational therapies for breast cancer. The study is laboratory based using human tissue samples and is hypothesis generating rather than a definitive trial. We will explore the potential of candidate proteins as future biomarkers or therapeutic targets. |
| Ethics approval(s) | Southampton and South West Hampshire Regional Ethics Committee, 09/11/2010, ref: 10/H0504/73 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | The study is non-interventional and laboratory-based. This research is hypothesis-generating rather than a clinical trial. Biomarker identification, validation and therapeutic targets. |
| Intervention type | Other |
| Primary outcome measure(s) |
Anticipated outcomes from this study are expression levels of candidate biomarkers in breast cancer. The expression levels will be evaluated by various means, but of this study is to determine the optimum methods of biomarker validation. |
| Key secondary outcome measure(s) |
Identify other proteins related to BAG-1 as possible biomarkers in breast cancer and therapeutic targets |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 500 |
| Key inclusion criteria | All tissue will be obtained from pre-existing sources (tissue bank, archival material surplus to diagnostic requirements, tissue microarrays generated for research purpose). There will be no active patient participation. |
| Key exclusion criteria | All tissue will be obtained from pre-existing sources (tissue bank, archival material surplus to diagnostic requirements, tissue microarrays generated for research purpose). There will be no active patient participation. |
| Date of first enrolment | 10/11/2010 |
| Date of final enrolment | 01/10/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/03/2020: The recruitment end date and overall trial end date were changed from 01/10/2020 to 01/10/2025.
11/04/2016: The overall trial end date was changed from 10/11/2015 to 01/10/2020
