Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer (CTC-MBC)

This study is currently recruiting participants.
Verified October 2013 by Lund University Hospital
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01322893
First received: March 24, 2011
Last updated: October 22, 2013
Last verified: October 2013

March 24, 2011
October 22, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
To determine whether numbers of circulating tumour cells in peripheral blood can give information of prognosis, and to evaluate if the numbers of circulating tumour cells can give information of the efficacy of given treatment [ Time Frame: Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01322893 on ClinicalTrials.gov Archive Site
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Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

Women with metastatic breast cancer, receiving first line treatment of any kind (chemotherapy, endocrine treatment or treatment with antibodies) will be included in this trial. In connection to treatment, blood samples for determination and enumeration of circulating tumour cells will be collected at different time points. Serum and plasma will be collected and stored for future analysis of RNA and DNA.

Not Provided
Observational
Time Perspective: Prospective
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Probability Sample

Women with metastatic breast cancer

Metastatic Breast Cancer
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Blood sampling.
Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with metastatic breast cancer
  • ECOG performance status 0-2
  • Age over18 years
  • Signed informed concent
  • Predicted life expectancy over 2 months
  • Planned for first line systemic treatment for metastatic disease (chemotherapy, antibody treatment or endocrine treatment)
  • Standard imaging evaluation within 4 weeks of inclusion
  • Planned for standard imaging within 16 weeks after start of therapy

Exclusion Criteria:

  • Prior medical therapy for metastatic disease (prior adjuvant chemotherapy, radiotherapy or endocrine therapy is permitted)
  • Inability to understand information about the study
  • Other malignant disease with the exception of curatively treated basal cell or squamous cell cancer of the skin and cancer in situ of the cervix
Female
18 Years and older
No
Contact: Lisa Ryden, MD, PhD +46 46 17 10 00 lisa.ryden@med.lu.se
Contact: Anette Ahlin Gullers, RN +46 46 17 76 34 anette.ahlingullers@skane.se
Sweden
 
NCT01322893
Version2. 2011-03-03
No
Lund University Hospital
Lund University Hospital
Not Provided
Not Provided
Lund University Hospital
October 2013

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