A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01344109|
Recruitment Status : Withdrawn (Lab company that was to do testing was sold)
First Posted : April 28, 2011
Last Update Posted : July 21, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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.
- 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 ]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
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): 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|