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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT01231386 |
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Date of registration:
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27/10/2010 |
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Primary sponsor: |
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Public title:
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MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer
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Scientific title:
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MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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165 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01231386 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort
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Countries of recruitment
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United States
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Contacts
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Name:
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Michele Kirschenbaum |
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Address:
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Telephone:
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800-826-4673 |
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Email:
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mkirschenbaum@coh.org |
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Affiliation:
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Name:
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George Somlo, MD |
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Address:
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Telephone:
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800 826-4673 |
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Email:
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gsomlo@coh.org |
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Affiliation:
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Name:
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George Somlo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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City of Hope Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female,
- Breast Cancer
- > 18 years,
- regardless of histology, treatment phase, or stage
Exclusion Criteria:
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Primary Outcome(s)
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Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum
[Time Frame: 3 years after competion of sample collection]
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Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points
[Time Frame: 3 years after completion of sample collection]
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Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade
[Time Frame: 3 years after completion of sample collection]
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Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression
[Time Frame: 3 years after completion of sample collection]
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Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs
[Time Frame: 3 years after completion of sample collection]
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Determination of specific miRNA functions
[Time Frame: 3 years after completion of sample collection]
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Performance of miRNA profiling from tumor samples from primary breast tumors
[Time Frame: 3 years after completion of sample collection]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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