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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Lab company that was to do testing was sold)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
Information provided by (Responsible Party):
Susan E. Eubanks, RN, MSN, OCN, Leo W. Jenkins Cancer Center

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.

Condition or disease
Breast Neoplasms

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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : February 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. 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
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed breast cancer patients prior to neoadjuvant chemotherapy treatment and healthy volunteers

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01344109

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United States, North Carolina
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
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Principal Investigator: Rachel Raab, MD Brody School of Medicine at ECU
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Responsible Party: Susan E. Eubanks, RN, MSN, OCN, Clinical Trials Manager, Leo W. Jenkins Cancer Center Identifier: NCT01344109    
Other Study ID Numbers: ECU 003
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases