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Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00156273
First received: September 7, 2005
Last updated: June 2, 2016
Last verified: June 2016

September 7, 2005
June 2, 2016
April 2005
October 2008   (final data collection date for primary outcome measure)
To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs [ Time Frame: Prospective ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00156273 on ClinicalTrials.gov Archive Site
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Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer
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
We are trying to develop better ways to detect when cancer therapies are working.
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Observational
Time Perspective: Prospective
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Probability Sample
women with metastatic breast cancer
Metastatic Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
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October 2008   (final data collection date for primary outcome measure)

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

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 -

Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00156273
UMCC 2003.075, HUM 45808 Legacy 2004-0703
Yes
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University of Michigan Cancer Center
University of Michigan Cancer Center
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Principal Investigator: Jeffrey Smerage, M.D., Ph.D. University of Michigan Cancer Center
University of Michigan Cancer Center
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP