A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy|
- To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy [ Time Frame: up to 2 years from start of study ] [ Designated as safety issue: No ]Compare tumor derived exosomes at baseline, monthly during chemotherapy, at the completion of chemotherapy treatment, and after surgery to determine residual cancer burden. Tumor derived exosome expression will be correlated with both clinical and pathologic response.
Biospecimen Retention: Samples With DNA
Serum will be centrifuged to plasma which will be transferred to alliquots, and frozen prior to shipping. Exosomes will be extracted from the frozen plasma with half of the sample used for antibody testing and the remaining sample will be used for RNA analysis.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Breast cancer patients
Newly diagnosed patients with breast cancer presenting with operable breast tumor prior to initiation of of neoadjuvant chemotherapy (choice of chemotherapy will be the the treating physician's discretion)
Adult women without a cancer diagnosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344109
|United States, North Carolina|
|Leo W. Jenkins Cancer Center|
|Greenville, North Carolina, United States, 27834|
|Principal Investigator:||Rachel Raab, MD||Brody School of Medicine at ECU|