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Life sciences · Observational Study
ClinicalTrials.gov · October 22, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT01231386). This is a study registration, not published results. Lead sponsor: City of Hope Medical Center. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 199 participants (ACTUAL). Conditions: Breast Cancer. Primary outcome measures: Performance of miRNA profiling from tumor samples from primary breast tumors , 3 years after completion of sample collection; Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points , 3 years after completion of sample collection; Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum , 3 years after competion of sample collection; Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade , 3 years after completion of sample collection; Determination of specific miRNA functions , 3 years after completion of sample collection; Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs , 3 years after completion of sample collection; Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression , 3 years after completion of sample collection. Brief summary: MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation and renewal both under physiologically normal as well as in malignant conditions. Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies. In this proposal, specimens from patients treated in the clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be applied to develop specific therapies.