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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156273
First Posted: September 12, 2005
Last Update Posted: July 5, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose
We are trying to develop better ways to detect when cancer therapies are working.

Condition
Metastatic Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

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

Enrollment: 69
Study Start Date: April 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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


Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
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 Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: July 5, 2017
Last Verified: July 2017

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