Breast CancerNCT02921152
Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
A study testing bone marrow aspiration /trephine biopsy in people with Breast Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- bone marrow aspiration /trephine biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University School of Medicine
Istanbul, 34515
Deniz Boler, Ass Prof, 5326458259, denniseren@yahoo.com
Cihan Uras, Prof
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- bone marrow aspiration /trephine biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow aspiration /trephine biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| all | Other | All patients with early breast cancer Receives: Procedure: bone marrow aspiration /trephine biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bone marrow metastases in early stage breast cancer
Number of patients with bone marrow metastases/ total number of enrolled patients
Measured: up to 5 years
Rate of sentinel lymph node metastases in early stage breast cancer
Measured: up to 5 years
Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
Measured: up to 5 years
Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
Measured: up to 5 years
Incidence of bone marrow metastases in triple negative early stage breast cancer
Measured: up to 5 years
Secondary outcomes (2)
Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
Measured: Up to 10 years
Overall survival
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921152
- Sponsor's protocol ID
- ATADEK 2015/11
- Status last verified
- Aug 2016
- First submitted
- 17 May 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02921152
- Acronym / sponsor ID
- ATADEK 2015/11
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all | Other | Procedure: bone marrow aspiration /trephine biopsyAll patients with early breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone marrow aspiration /trephine biopsy | Procedure or surgery | all |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone marrow aspiration /trephine biopsy in people with Breast Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bone marrow metastases in early stage breast cancer (time frame: up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.