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

This study is currently recruiting participants.
Verified April 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: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Metastatic Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Enumeration and Molecular Characterization of Circulating Tumour Cells in Women With Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blood sampling.
Blood samples will be taken before start of treatment, at month 1, month 3, month 4 and month 6.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322893

Contacts
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

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Anna-Maria Larsson, MD     +46 46 17 10 00     anna-maria.larsson@med.lu.se    
Contact: Anette Ahlin Gullers, RN     +46 46 17 76 34     anette.ahlingullers@skane.se    
Principal Investigator: Lisa Rydén, MD, PhD            
Sponsors and Collaborators
Lund University Hospital
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01322893     History of Changes
Other Study ID Numbers: Version2. 2011-03-03
Study First Received: March 24, 2011
Last Updated: April 19, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University Hospital:
Metastatic breast cancer
Circulating tumour cells
CTC
Prognostic factors
Treatment response

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013