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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.
Verified April 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00353483
First Posted: July 18, 2006
Last Update Posted: April 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: Peripheral blood draw Procedure: Breast tissue collection Procedure: Bone marrow biopsy

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/or bone marrow may be collected at that following times:

  • Participants planning to undergo neoadjuvant chemo:

    • 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
  • Participants who have undergone neoadjuvant chemo:

    • during definitive cancer surgery or portacath removal (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
  • An attempt will be made to collect blood on all patients once a year for 5 years from the time of enrollment
Procedure: Peripheral blood draw Procedure: Breast tissue collection Procedure: Bone marrow biopsy

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:

  • Recently diagnosed with clinical stage II, III, or IV breast cancer
  • Planning to undergo neoadjuvant chemotherapy; patients who have already completed neoadjuvant chemotherapy are also eligible
  • Must >= 18 years of age
  • If female, must not be pregnant
  • Must be willing and able to sign informed consent document
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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: 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: Shunqiang Li, MD         
Sub-Investigator: Julie Margenthaler, MD         
Sub-Investigator: Cynthia Ma, MD         
Sub-Investigator: Amy Cyr, MD         
Sub-Investigator: Katherine Glover-Collins, MD, PhD         
Sub-Investigator: Antonella Rastelli, MD         
Sub-Investigator: Caron Rigden, MD         
Sub-Investigator: Rama Suresh, MD         
Sub-Investigator: Gregory Longmore, MD         
Sub-Investigator: Ashley Frith, MD         
Sub-Investigator: Foluso Ademuyiwa, MD         
Sub-Investigator: Peter Oppelt, MD         
Sub-Investigator: Haeseong Park, MD         
Sub-Investigator: Ron Bose, MD, PhD         
Sub-Investigator: Leonel Hernandez Aya, MD         
Sub-Investigator: Mathew Cherian, MD         
Sub-Investigator: Lindsay Peterson, MD         
Sub-Investigator: Cara Cipriano, 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
First Submitted: July 17, 2006
First Posted: July 18, 2006
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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