Condition category
Cancer
Date applied
09/05/2011
Date assigned
21/09/2011
Last edited
11/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2020

Who is funding the study?
Cancer Research UK

Who is the main contact?
Mr Ramsey Cutress
r.i.cutress@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ramsey Cutress

ORCID ID

Contact details

CRUK Centre
Somers Building
Mailpoint 824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 5170 / 6184
r.i.cutress@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHMCAN0738 (Protocol version 1.3 )

Study information

Scientific title

Breast cancer biomarkers translational research and validation study

Acronym

Study hypothesis

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

Southampton and South West Hampshire Regional Ethics Committee, 09/11/2010, ref: 10/H0504/73

Study design

Open-label non-randomised retrospective study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient confidentiality will be maintained by removing patient identifiable labels other than an assigned study specific number to create linked anonymised samples. No personally identifying information will be realeased in any report or publication relating to this work.

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Validate BAG-1 as a bimomarker in breast cancer

Secondary outcome measures

Identify other proteins related to BAG-1 as possible biomarkers in breast cancer and therapeutic targets

Overall trial start date

10/11/2010

Overall trial end date

01/10/2020

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Over 500 samples are currently held in the tissue bank at present

Participant 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.

Recruitment start date

10/11/2010

Recruitment end date

01/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CRUK Centre
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital Southampton (UK)

Sponsor details

R&D Office
E Level
Southampton Centre for Biomedical Research
Laboratory and Pathology block
mailpoint 138
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 5044
RDoffice@uhs.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 11/04/2016 the overall trial end date was changed from 10/11/2015 to 01/10/2020