Breast Cancer Proteomics and Molecular Heterogeneity

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01840293
First received: April 23, 2013
Last updated: August 11, 2014
Last verified: August 2014

April 23, 2013
August 11, 2014
February 2013
February 2023   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01840293 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Breast Cancer Proteomics and Molecular Heterogeneity
Breast Cancer Proteomics and Molecular Heterogeneity

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

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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.

  • Primary Breast Cancer
  • Recurrent/Metastatic Breast Cancer
Not Provided
  • Primary Breast Cancer
  • Recurrent/Metastatic Breast Cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1780
Not Provided
February 2023   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Ireland
 
NCT01840293
ICORG 09-07
No
ICORG- All Ireland Cooperative Oncology Research Group
ICORG- All Ireland Cooperative Oncology Research Group
Not Provided
Not Provided
ICORG- All Ireland Cooperative Oncology Research Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP