NCT02921152

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

May 17, 2016

Last Update Submit

September 29, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

  • Rate of bone marrow metastases in early stage breast cancer

    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

    up to 5 years

  • Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer

    up to 5 years

  • Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer

    up to 5 years

  • Incidence of bone marrow metastases in triple negative early stage breast cancer

    up to 5 years

Secondary Outcomes (2)

  • Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy

    Up to 10 years

  • Overall survival

    up to 10 years

Other Outcomes (1)

  • Disease free survival

    up to 10 years

Study Arms (1)

all

OTHER

All patients with early breast cancer

Procedure: bone marrow aspiration /trephine biopsy

Interventions

bone marrow aspiration /trephine biopsyPROCEDURE
all

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active collagen tissue disorders
  • Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study
  • Pregnancy
  • Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.
  • Patients who refused to enter the study protocol and refused to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University School of Medicine

Istanbul, 34515, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

October 3, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2021

Last Updated

October 3, 2016

Record last verified: 2016-08

Locations

TU(1)