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Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT02921152
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Acibadem University

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date October 3, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Rate of bone marrow metastases in early stage breast cancer [ Time Frame: up to 5 years ]
    Number of patients with bone marrow metastases/ total number of enrolled patients
  • Rate of sentinel lymph node metastases in early stage breast cancer [ Time Frame: up to 5 years ]
  • Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer [ Time Frame: up to 5 years ]
  • Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer [ Time Frame: up to 5 years ]
  • Incidence of bone marrow metastases in triple negative early stage breast cancer [ Time Frame: up to 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy [ Time Frame: Up to 10 years ]
  • Overall survival [ Time Frame: up to 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 29, 2016)
Disease free survival [ Time Frame: up to 10 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Official Title  ICMJE Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Brief Summary Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE Procedure: bone marrow aspiration /trephine biopsy
Study Arms  ICMJE all
All patients with early breast cancer
Intervention: Procedure: bone marrow aspiration /trephine biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients over 18 years old and who have given informed consent to enter the study.
  2. ASA I-II patients
  3. Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study
  4. Patients who are appropriate for bone marrow biopsy
  5. Menopausal status is not relevant.

Exclusion criteria:

  1. Active collagen tissue disorders
  2. Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study
  3. Pregnancy
  4. Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.
  5. Patients who refused to enter the study protocol and refused to give informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921152
Other Study ID Numbers  ICMJE ATADEK 2015/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Acibadem University
Study Sponsor  ICMJE Acibadem University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Acibadem University
Verification Date August 2016

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