Clinical trial · Interventional
Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow aspiration /trephine biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- all
- description
- All patients with early breast cancer
- interventionNames
- Procedure: bone marrow aspiration /trephine biopsy
Primary outcomes (5)
- measure
- Rate of bone marrow metastases in early stage breast cancer
- timeFrame
- up to 5 years
- description
- Number of patients with bone marrow metastases/ total number of enrolled patients
- measure
- Rate of sentinel lymph node metastases in early stage breast cancer
- timeFrame
- up to 5 years
- measure
- Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available