Breast Cancer Proteomics and Molecular Heterogeneity
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|ClinicalTrials.gov Identifier: NCT01840293|
Recruitment Status : Recruiting
First Posted : April 25, 2013
Last Update Posted : August 10, 2017
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
|Condition or disease|
|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.
|Study Type :||Observational|
|Estimated Enrollment :||1780 participants|
|Official Title:||Breast Cancer Proteomics and Molecular Heterogeneity|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2023|
|Primary Breast Cancer|
|Recurrent/Metastatic Breast Cancer|
- Investigation of proteins and their pathways in primary breast cancer [ Time Frame: 10 years ]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 ]
- Identification of novel molecular mechanisms of breast cancer recurrence [ Time Frame: 10 years ]Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
- Determination of novel potential molecular targets [ Time Frame: 10 years ]Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|