A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

This study is currently recruiting participants.

Verified January 2012 by Leo W. Jenkins Cancer Center

Sponsor:

Information provided by (Responsible Party):

Jackie Unger, Leo W. Jenkins Cancer Center

ClinicalTrials.gov Identifier:

NCT01344109

First received: April 27, 2011

Last updated: January 3, 2013

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 27, 2011
Last Updated Date	January 3, 2013
Start Date ^ICMJE	February 2011
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 27, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01344109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official Title ^ICMJE	A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: 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.
Sampling Method	Non-Probability Sample
Study Population	Newly diagnosed breast cancer patients prior to neoadjuvant chemotherapy treatment and healthy volunteers
Condition ^ICMJE	Breast Neoplasms
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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) Healthy volunteers Adult women without a cancer diagnosis.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women with biopsy proven invasive carcinoma of the breast Women with locally advanced breast cancer and breast tumors measuring >/= 2cm who are deemed candidates for preoperative chemotherapy Age >/= 18 years old Expected survival >/= 6 months Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of study Initial required laboratory values: Absolute neutrophil count >/= 1.5 x 10(9)/L Platelet count >/= 100,000 x 10(9)/L Creatinine clearance >/= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) </= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential) Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials Exclusion Criteria: No prior chemotherapy for breast cancer No limitations for prior radiation therapy No active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial Non-pregnant and non-nursing patients only. Patients of reproductive potential must agree to use an effective means of birth control No prior liver transplant or bone marrow transplant
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01344109
Other Study ID Numbers ^ICMJE	ECU 003
Has Data Monitoring Committee	No
Responsible Party	Jackie Unger, Leo W. Jenkins Cancer Center
Study Sponsor ^ICMJE	Leo W. Jenkins Cancer Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Leo W. Jenkins Cancer Center
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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