Randomized Controlled Trial to Evaluate the Role of Iatrogenic Displacement of Tumor cells to Axillary Lymph Nodes.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- To study the incidence of Iatrogenic Displacement of Tumor Cells in afferent lymphatics as a consequence of tumor handling
研究概览
简要总结
Rationale: Axillary nodal status in patients with carcinoma of thebreast is one of the strongest prognostic factors and also an importantdeterminant on decisions foradjuvant treatment. The role of isolated tumor cells (ITCs) and circulatingtumor cells (CTCs) and their clinical significance remains to be established.Studies have shown that tumor manipulation causes an increase in the CTCs. Apopulation-based study from Denmark has shown an increase in the ITCs in theaxillary nodes secondary to tumor handling. Prospective data on the same arelacking. We aim to study if tumor manipulation causing increased ITC.
Methodology: The trial is a Randomized controlled trial inpatients of breast carcinoma presenting with clinically negative nodes,eligible for breast conservation surgery. Patients will be randomized into twogroups, namely axilla first or primary first.
The protocol would not impact the overall treatment plan of thepatients, or have a bearing on the cost of treatment. The detection of the ITCswould require additional immune-histochemistry studies, for which funding wouldbe required
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patient with breast cancer age 18 years and above 2.T1 N0 / T2 N0 tumours 3.Patient undergoing upfront breast conserving surgery 4.Willing to give consent to participate in the study.
排除标准
- •1.Previous h/o lumpectomy or incision biopsy 2.Patient planned for Neoadjuvant Chemotherapy 3.Locally advanced or metastatic breast tumours 4.Lactating patients.
结局指标
主要结局
To study the incidence of Iatrogenic Displacement of Tumor Cells in afferent lymphatics as a consequence of tumor handling
时间窗: 30 days after surgery
次要结局
- 1.To study the incidence of micrometastases in afferent lymphatics as a consequence of tumor handling
- 2.To study the impact of ITCs on disease free survival(5 years)