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Trial record 1 of 1 for:    NCT00353483
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Effect of Chemotherapy Administered Before Surgery on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00353483
First received: July 17, 2006
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

Condition Intervention
Breast Neoplasms
Procedure: Blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Characterize tumor markers expressed by DTC which are present after chemotherapy. [ Time Frame: Approximately 6 years ]
  • Compare the expression of these markers to that on DTC detected prior to chemotherapy. [ Time Frame: Approximately 6 years ]
  • Correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence. [ Time Frame: Approximately 6 years ]
  • Compare the tumor markers present on DTC before and after chemotherapy with the tumor marker expression of the primary tumor and post-treatment tumor. [ Time Frame: Approximately 6 years. ]
  • To xenograft tumor cells into mice for further genetic and phenotypic characterization. [ Time Frame: Approximately 5-11 years. ]

Biospecimen Retention:   Samples With DNA
Breast cancer tissue, peripheral blood, and bone marrow

Estimated Enrollment: 200
Actual Study Start Date: September 14, 2005
Estimated Study Completion Date: August 31, 2021
Estimated Primary Completion Date: August 31, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tissue, blood, and bone marrow collection

Breast cancer tissue, peripheral blood, and bone marrow will be collected at that following times:

  • at the time of initial surgery for a sentinel lymph node biopsy or portacath placement
  • during definitive cancer surgery (if surgery occurs)
  • at one year, when portacath is removed (if available)
  • if metastatic disease (nodules, pleural effusion, or other metastatic disease) develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis

All patients will undergo blood collection once a year for 5 years from the time of enrollment

Procedure: Blood draw

Detailed Description:
In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after chemotherapy represent a unique subpopulation of all DTC, are predictors of a poor response to chemotherapy, and correlate with poor clinical outcome. The investigators hypothesize that chemotherapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after chemotherapy, 2) to compare the expression of these markers to that on DTC detected prior to chemotherapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in clinic at Washington University School of Medicine.
Criteria

Inclusion Criteria:

  • Must be newly diagnosed with clinical stage II, III, or IV breast cancer who will undergo neoadjuvant chemotherapy (chemotherapy prior to surgery)
  • Must >= 18 years of age
  • If female, must not be pregnant
  • Must be willing and able to sign informed consent document
  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 ClinicalTrials.gov identifier: NCT00353483

Contacts
Contact: Rebecca Aft, MD, PhD 314-747-0063 aftr@wustl.edu
Contact: Tracey Guthrie 314-747-4404 guthriet@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63119
Contact: Rebecca Aft, MD, PhD    314-747-0063    aftr@wustl.edu   
Contact: Tracey Guthrie    314-747-4404    guthriet@wustl.edu   
Principal Investigator: Rebecca Aft, MD, PhD         
Sub-Investigator: Mark Watson, MD, PhD         
Sub-Investigator: Lourdes Ylagan, MD         
Sub-Investigator: Tim Fleming, PhD         
Sub-Investigator: William Gillanders, MD         
Sub-Investigator: Timothy Eberlein, MD         
Sub-Investigator: Katherine Weilbaecher, MD         
Sub-Investigator: Michael Naughton, MD         
Sub-Investigator: Loren Michel, MD         
Sub-Investigator: Shunqiang Li, MD         
Sub-Investigator: Julie Margenthaler, MD         
Sub-Investigator: Cynthia Ma, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00353483     History of Changes
Other Study ID Numbers: 05-0648 / 201101961
Study First Received: July 17, 2006
Last Updated: February 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Breast Cancer
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Bone Marrow Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on March 28, 2017