Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer

September 29, 2016 updated by: Acibadem University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34515
        • Recruiting
        • Acibadem University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Cihan Uras, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: all
All patients with early breast cancer
Procedure: bone marrow aspiration /trephine biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years
Rate of sentinel lymph node metastases in early stage breast cancer
Time Frame: up to 5 years
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
up to 5 years
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
Time Frame: up to 5 years
up to 5 years
Incidence of bone marrow metastases in triple negative early stage breast cancer
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
Time Frame: Up to 10 years
Up to 10 years
Overall survival
Time Frame: up to 10 years
up to 10 years

Other Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: up to 10 years
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2015/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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