Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1780 participants
OBSERVATIONAL
2013-02-28
2038-01-31
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Primary Breast Cancer
No interventions assigned to this group
Recurrent/Metastatic Breast Cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Cancer Trials Ireland
NETWORK
Responsible Party
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Locations
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Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
University Hospital Limerick
Limerick, , Ireland
University Hospital Waterford
Waterford, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Cancer Clinical Trials Unit
Role: primary
Contact Person
Role: primary
CCRT
Role: primary
Cancer Clinical Trials Office
Role: primary
References
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Charmsaz S, Doherty B, Cocchiglia S, Vareslija D, Marino A, Cosgrove N, Marques R, Priedigkeit N, Purcell S, Bane F, Bolger J, Byrne C, O'Halloran PJ, Brett F, Sheehan K, Brennan K, Hopkins AM, Keelan S, Jagust P, Madden S, Martinelli C, Battaglini M, Oesterreich S, Lee AV, Ciofani G, Hill ADK, Young LS. ADAM22/LGI1 complex as a new actionable target for breast cancer brain metastasis. BMC Med. 2020 Nov 19;18(1):349. doi: 10.1186/s12916-020-01806-4.
Charmsaz S, Hughes E, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100beta as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2.
Other Identifiers
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ICORG 09-07
Identifier Type: -
Identifier Source: org_study_id