Breast Cancer Proteomics and Molecular Heterogeneity
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
- 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
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer
|Study Design:||Observational Model: Cohort|
|Official Title:||Breast Cancer Proteomics and Molecular Heterogeneity|
- Investigation of proteins and their pathways in primary breast cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
- Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Identification of novel molecular mechanisms of breast cancer recurrence [ Time Frame: 10 years ] [ Designated as safety issue: No ]Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
- Determination of novel potential molecular targets [ Time Frame: 10 years ] [ Designated as safety issue: No ]Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||February 2023 (Final data collection date for primary outcome measure)|
|Primary Breast Cancer|
|Recurrent/Metastatic Breast Cancer|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840293
|St. Vincent's University Hospital||Recruiting|
|Dublin 4, Ireland|
|Contact: Cancer Trials 01 221 4000|
|Contact: Contact Person 01- 809 3000|
|Principal Investigator: Arnold Hill, Prof|
|Principal Investigator: Bryan Hennessy, Prof|