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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

Tracking Information
First Submitted Date April 23, 2013
First Posted Date April 25, 2013
Last Update Posted Date February 26, 2020
Study Start Date February 2013
Estimated Primary Completion Date December 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2013)
  • Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer [ Time Frame: 10 years ]
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Cancer Proteomics and Molecular Heterogeneity
Official Title Breast Cancer Proteomics and Molecular Heterogeneity
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.
Condition
  • Primary Breast Cancer
  • Recurrent/Metastatic Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Primary Breast Cancer
  • Recurrent/Metastatic Breast Cancer
Publications * Charmsaz S, Hughes É, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100β as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2013)
1780
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2029
Estimated Primary Completion Date December 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840293
Other Study ID Numbers ICORG 09-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date February 2020