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

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ClinicalTrials.gov Identifier: NCT00156273
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
We are trying to develop better ways to detect when cancer therapies are working.

Condition or disease
Metastatic Breast Cancer

Study Design

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Other
Time Perspective: 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
Study Start Date : April 2005
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs [ Time Frame: Prospective ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

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 -

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): NCT00156273

United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Jeffrey Smerage, M.D., Ph.D. University of Michigan Cancer Center
More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00156273     History of Changes
Other Study ID Numbers: UMCC 2003.075
HUM 45808 Legacy 2004-0703 ( Other Identifier: University of Michigan IRBMED )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases