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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 : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Study Description
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Brief Summary:

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 or disease
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1780 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Breast Cancer Proteomics and Molecular Heterogeneity
Study Start Date : February 2013
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer [ Time Frame: 10 years ]
  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840293


Locations
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Ireland
St. Vincent's University Hospital Recruiting
Dublin 4, Ireland
Contact: Cancer Trials    01 221 4000      
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01- 809 3000      
Principal Investigator: Arnold Hill, Prof         
Principal Investigator: Bryan Hennessy, Prof         
Sponsors and Collaborators
Cancer Trials Ireland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01840293    
Other Study ID Numbers: ICORG 09-07
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases