Breast Cancer Proteomics and Molecular Heterogeneity
Conditions
Primary Breast Cancer - Recurrent/Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort
Overall Status
Recruiting
Summary
Primary objective:

The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes

Secondary objective:

- To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.

- To relate proteomic findings to survival data

- To identify potential serum markers of breast cancer progression
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Beaumont Hospital
Dublin, Ireland
Status: Recruiting
Contact: Contact Person - 01- 809 3000
Start Date
February 2013
Sponsors
ICORG- All Ireland Cooperative Oncology Research Group
Source
ICORG- All Ireland Cooperative Oncology Research Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page