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

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.
 
ClinicalTrials.gov Identifier: NCT01322893
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Brief Summary:
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.

Condition or disease
Metastatic Breast Cancer

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer
Study Start Date : March 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Blood sampling.
Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.



Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with metastatic breast cancer
Criteria

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

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): NCT01322893


Locations
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Sweden
Lund University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01322893    
Other Study ID Numbers: Version2. 2011-03-03
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2019
Keywords provided by Lund University Hospital:
Metastatic breast cancer
Circulating tumour cells
CTC
Prognostic factors
Treatment response
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes