This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been withdrawn prior to enrollment.
(Lab company that was to do testing was sold)
Information provided by (Responsible Party):
Jackie Unger, Leo W. Jenkins Cancer Center Identifier:
First received: April 27, 2011
Last updated: August 26, 2013
Last verified: August 2013
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.

Breast Neoplasms

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Jackie Unger, Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • 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.

Enrollment: 0
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)
Healthy volunteers
Adult women without a cancer diagnosis.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01344109

United States, North Carolina
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Principal Investigator: Rachel Raab, MD Brody School of Medicine at ECU
  More Information

Responsible Party: Jackie Unger, Clinical Trials Manager, Leo W. Jenkins Cancer Center Identifier: NCT01344109     History of Changes
Other Study ID Numbers: ECU 003
Study First Received: April 27, 2011
Last Updated: August 26, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on June 22, 2017