Breast Cancer Proteomics and Molecular Heterogeneity

This study is currently recruiting participants.
Verified January 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: January 23, 2014
Last verified: January 2014
  Purpose

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

Condition
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Breast Cancer Proteomics and Molecular Heterogeneity

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1780
Study Start Date: February 2013
Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840293

Locations
Ireland
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01- 809 3000      
Principal Investigator: Arnold Hill, Prof         
Principal Investigator: Bryan Hennessy, Prof         
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
  More Information

No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT01840293     History of Changes
Other Study ID Numbers: ICORG 09-07
Study First Received: April 23, 2013
Last Updated: January 23, 2014
Health Authority: Ireland: Health Information and Quality Authority

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014