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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01322893
First received: March 24, 2011
Last updated: September 19, 2016
Last verified: September 2016

March 24, 2011
September 19, 2016
March 2011
June 2017   (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
Not Provided
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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
Not Provided
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.
 
Active, not recruiting
150
June 2017
June 2017   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01322893
Version2. 2011-03-03
No
Not Provided
Not Provided
Lund University Hospital
Lund University Hospital
Not Provided
Not Provided
Lund University Hospital
September 2016

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