Breast Cancer Proteomics and Molecular Heterogeneity

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014