Breast Cancer Proteomics and Molecular Heterogeneity
18 Years
N/A
Female
Primary Breast Cancer, Recurrent/Metastatic Breast Cancer
Trial Information
Breast Cancer Proteomics and Molecular Heterogeneity
This is a translational study. Patient will undergo standard treatment and tissue and blood
samples will be taken at various time points:
Tissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be
collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue.
Blood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid
(EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively
of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no
biopsy/surgery required then study bloods will be taken prior to starting treatment).
Additional blood samples will be taken annually at follow-up visits for 5 years from primary
cases and for up to 2 years from recurrent/metastatic cases.
Non-heparinised blood will be processed to serum. Clinical data will be collected at all
times of biological sampling.
Inclusion Criteria:
1. Patients diagnosed with primary breast cancer attending hospital for the resection of
their tumour tissue
Or
-Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient
has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary
breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour
tissue
Or
-Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage
4 breast cancer attending hospital for the resection/biopsy and/or treatment of their
tumour tissue
2. Patients receiving neoadjuvant treatment are also eligible (if applicable)
3. Patients have to be ≥ 18 years of age
4. Patients must be able to give informed consent
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Outcome Measure:
Investigation of proteins and their pathways in primary breast cancer
Outcome Description:
Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
Outcome Time Frame:
10 years
Safety Issue:
No
Authority:
Ireland: Health Information and Quality Authority
Study ID:
ICORG 09-07
NCT ID:
NCT01840293
Start Date:
February 2013
Completion Date:
Related Keywords:
- Primary Breast Cancer
- Recurrent/Metastatic Breast Cancer
- Breast Neoplasms
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