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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00156273 |
We are trying to develop better ways to detect when cancer therapies are working.
Condition |
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Metastatic Breast Cancer |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Pilot Study to Determine the Feasibility of Quantifying Apoptosis and Bcl-2 Expression in Circulating Tumor Cells (CTCs) in Women Undergoing Treatment for Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
women with metastatic breast cancer
Inclusion Criteria:
1.Females at least 18 years of age 2 Diagnosis of metastatic breast cancer 3.ECOG Score of 0-2 4.Treating oncologist has decided to initiate any new systemic therapy with emphasis on recruiting patients commencing a taxane-based regimen. Taxine-based therapy may be docetaxel or paclitaxel, and it can be given on any schedule,including weekly or every 3 weeks. Other treatment can include non-taxane chemotherapy or trastuzumab-with or without other therapy.
5.Patient is willing to return for one or more additional ~18 mL blood draw (s) at 24-48-, and /or 72 hours and ~3-4 weeks after the initiation of therapy.At a minimum, patients must donate blood at baseline, one intermediate interval (24, 48, 72 hr) and at ~3-4 weeks 6.Signed Informed Consent Form
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Exclusion Criteria:
Patient is unable and unwilling to provide a blood specimen at a minimum of one of the intermediate blood draw time points at 24, 48, or 72 hours -
United States, Michigan | |
University of Michigan Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Cancer Answer Line 800-865-1125 | |
Contact: Judy Luckhardt, RN 734-647-5345 jluck@umich.edu | |
Principal Investigator: Jeffrey Smerage, M.D. |
Principal Investigator: | Jeffrey Smerage, M.D., Ph.D. | University of Michigan Cancer Center |
Responsible Party: | U of M ( Cancer Answer Line ) |
Study ID Numbers: | UMCC 2003.075 |
Study First Received: | September 7, 2005 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00156273 |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |