Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 1807 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: bone marrow aspiration /trephine biopsy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
all
All patients with early breast cancer
Procedure: bone marrow aspiration /trephine biopsy



Primary Outcome Measures :
  1. 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

  2. Rate of sentinel lymph node metastases in early stage breast cancer [ Time Frame: up to 5 years ]
  3. Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer [ Time Frame: up to 5 years ]
  4. Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer [ Time Frame: up to 5 years ]
  5. Incidence of bone marrow metastases in triple negative early stage breast cancer [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy [ Time Frame: Up to 10 years ]
  2. Overall survival [ Time Frame: up to 10 years ]

Other Outcome Measures:
  1. Disease free survival [ Time Frame: up to 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02921152


Locations
Layout table for location information
Turkey
Acibadem University School of Medicine Recruiting
Istanbul, Turkey, 34515
Contact: Deniz Boler, Ass Prof    5326458259    denniseren@yahoo.com   
Sub-Investigator: Cihan Uras, Prof         
Sponsors and Collaborators
Acibadem University

Layout table for additonal information
Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT02921152     History of Changes
Other Study ID Numbers: ATADEK 2015/11
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasm Micrometastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes